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.

Last updated 28 March 2024. Database contains 1080 unique substances/entries.
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97
72081/10
yes
no
Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.
Properties: Viscosity at 120 °C: > 3 Pa.s,Softening point: > 95 °C as determined by ASTM Method E 28-67,Bromine number: < 40 (ASTM D1159),The colour of a 50 % solution in toluene < 11 on the Gardner scale,Residual aromatic monomer ≤ 50 ppm.
Details
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-
68
73160
yes
yes
0.05 mg/kg
Details
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-
69
74400
yes
yes
30 mg/kg
Details
show/hide
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
2-ethylhexyl octyl phthalate EC / List no: 701-508-1 | CAS no: 3461-26-5
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
6-methylheptyl 8-methylnonyl phthalate EC / List no: 204-293-8 | CAS no: 119-05-1
1,2-Benzenedicarboxylic acid, bis-(1-ethylhexyl) ester EC / List no: - | CAS no: 15495-94-0
Isononyl isooctyl phthalate EC / List no: 306-190-4 | CAS no: 96532-79-5
Bis(1-methylheptyl) phthalate EC / List no: 205-014-2 | CAS no: 131-15-7
1,2-Benzenedicarboxylic acid, bis(2,5-dimethylhexyl) ester EC / List no: - | CAS no: 104719-70-2
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
2-ethylhexyl 8-methylnonyl phthalate EC / List no: 201-883-7 | CAS no: 89-13-4
2-ethylhexyl nonyl phthalate EC / List no: 288-646-1 | CAS no: 85851-86-1
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
2-ethylhexyl isodecyl phthalate EC / List no: 258-455-8 | CAS no: 53272-22-3
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
2-ethylhexyl isononyl phthalate EC / List no: 288-652-4 | CAS no: 85851-92-9
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
Diisooctyl phthalate EC / List no: 248-523-5 | CAS no: 27554-26-3
Bis(2-ethylhexyl) phthalate EC / List no: 204-211-0 | CAS no: 117-81-7
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Isodecyl isooctyl phthalate EC / List no: 255-760-8 | CAS no: 42343-35-1
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
1,2-Benzenedicarboxylic acid, bis(2-propylpentyl) ester EC / List no: - | CAS no: 70910-37-1
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728
75100
yes
no
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
show/hide
6-methylheptyl 8-methylnonyl phthalate EC / List no: 204-293-8 | CAS no: 119-05-1
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
2-ethylhexyl isodecyl phthalate EC / List no: 258-455-8 | CAS no: 53272-22-3
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Diisooctyl phthalate EC / List no: 248-523-5 | CAS no: 27554-26-3
Isononyl isooctyl phthalate EC / List no: 306-190-4 | CAS no: 96532-79-5
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
1,2-Benzenedicarboxylic acid, bis(2-propylpentyl) ester EC / List no: - | CAS no: 70910-37-1
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
Isodecyl isooctyl phthalate EC / List no: 255-760-8 | CAS no: 42343-35-1
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
2-ethylhexyl isononyl phthalate EC / List no: 288-652-4 | CAS no: 85851-92-9
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Bis(1-methylheptyl) phthalate EC / List no: 205-014-2 | CAS no: 131-15-7
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
2-ethylhexyl 8-methylnonyl phthalate EC / List no: 201-883-7 | CAS no: 89-13-4
1,2-Benzenedicarboxylic acid, bis(2,5-dimethylhexyl) ester EC / List no: - | CAS no: 104719-70-2
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
2-ethylhexyl nonyl phthalate EC / List no: 288-646-1 | CAS no: 85851-86-1
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
2-ethylhexyl octyl phthalate EC / List no: 701-508-1 | CAS no: 3461-26-5
Bis(2-ethylhexyl) phthalate EC / List no: 204-211-0 | CAS no: 117-81-7
1,2-Benzenedicarboxylic acid, bis-(1-ethylhexyl) ester EC / List no: - | CAS no: 15495-94-0
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-
728
75100
yes
no
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
show/hide
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
Diisoundecyl phthalate EC / List no: 306-165-8 | CAS no: 96507-86-7
Bis(2-methyldecyl) phthalate EC / List no: 288-643-5 | CAS no: 85851-83-8
Isononyl isoundecyl phthalate EC / List no: 285-920-2 | CAS no: 85168-79-2
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
Isodecyl isoundecyl phthalate EC / List no: 305-701-8 | CAS no: 94979-22-3
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
Bis(2-propyloctyl) phthalate EC / List no: 288-645-6 | CAS no: 85851-85-0
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
Bis(2-ethylnonyl) phthalate EC / List no: 288-641-4 | CAS no: 85851-82-7
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
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-
729
75105
yes
no
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.
Details
show/hide
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Bis(2-ethylnonyl) phthalate EC / List no: 288-641-4 | CAS no: 85851-82-7
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
Bis(2-propyloctyl) phthalate EC / List no: 288-645-6 | CAS no: 85851-85-0
Diisoundecyl phthalate EC / List no: 306-165-8 | CAS no: 96507-86-7
Bis(2-methyldecyl) phthalate EC / List no: 288-643-5 | CAS no: 85851-83-8
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
Isononyl isoundecyl phthalate EC / List no: 285-920-2 | CAS no: 85168-79-2
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
Isodecyl isoundecyl phthalate EC / List no: 305-701-8 | CAS no: 94979-22-3
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
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-
729
75105
yes
no
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.
Details
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-
820
76420
yes
no
Details
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147398-31-0
1059
no
no
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.
Details
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1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
Details
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90751-07-8
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
Details
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-
70
76463
yes
no
Details
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661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
Details
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167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
Details
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-
71
76730
yes
no
6 mg/kg
Details
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-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
Details
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-
73
76866
yes
yes
Details
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-
73
76866
yes
yes
Details
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-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
Details
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-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
Details
-
-
799
77708
yes
no
1.8 mg/kg
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
Details
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-
78
77897
yes
no
5 mg/kg
Details
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-
74
77440
yes
yes
42 mg/kg
Details
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-
75
77702
yes
no
Details
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-
79
80640
yes
no
Details
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-
80
81760
yes
no
Details
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-
81
83320
yes
no
Details
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-
82
83325
yes
no
Details
-
-
83
83330
yes
no
Details
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13445-56-2
609
83455
yes
no
Details
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-
84
85601
yes
no
Details
-
-
85
85610
yes
no
Details
-
-
86
86000
yes
no
Details
-
-
87
86285
yes
no
For synthetic amorphous silicon dioxide, silanated: primary particles of 1-100 nm which are aggregated to a size of 0,1-1 µm and may form agglomerates within the size distribution of 0,3 µm to the mm size.
Details
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-
88
86880
yes
no
9 mg/kg
Details
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-
89
89440
yes
no
Details
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-
821
90810
yes
no
Details
-
-
813
91530
yes
no
5 mg/kg
Details
-
-
814
91815
yes
no
2 mg/kg
Details
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-
90
92195
yes
no
Details
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-
91
92320
yes
yes
15 mg/kg
Details
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-
873
93460
yes
no
Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
Details
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-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
Details
-
-
805
93450
yes
no
The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w.
Details
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-
6
25380
no
no
0.05 mg/kg
Details
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-
5
25360
no
no
0.01 mg/kg
1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
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-
92
93970
yes
no
0.05 mg/kg
Details
-
-
815
94985
yes
no
5 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
-
-
815
94985
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
-
-
924
94987
yes
no
0.05 mg/kg
Only for use in PET in contact with all types of foods other than fatty, high- alcoholic and dairy products.
Details

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