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 17 June 2024. Database contains 1080 unique substances/entries.
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201-622-7
85-68-7
159
74560
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.
Details
204-211-0
117-81-7
283
74640
yes
no
0.6 mg/kg
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.
Details
204-211-0
117-81-7
283
74640
yes
no
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.
Details
204-211-0
117-81-7
283
74640
yes
no
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.
Details
205-016-3
131-17-9
316
23230
no
no
0.01 mg/kg
Details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
0.12 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
show/hide
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
Bis(2-ethylhexyl) phthalate EC / List no: 204-211-0 | CAS no: 117-81-7
1,2-Benzenedicarboxylic acid, bis(2-propylpentyl) ester EC / List no: - | CAS no: 70910-37-1
2-ethylhexyl octyl phthalate EC / List no: 701-508-1 | CAS no: 3461-26-5
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
6-methylheptyl 8-methylnonyl phthalate EC / List no: 204-293-8 | CAS no: 119-05-1
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
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
2-ethylhexyl isodecyl phthalate EC / List no: 258-455-8 | CAS no: 53272-22-3
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
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
Diisooctyl phthalate EC / List no: 248-523-5 | CAS no: 27554-26-3
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Bis(1-methylheptyl) phthalate EC / List no: 205-014-2 | CAS no: 131-15-7
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(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
2-ethylhexyl nonyl phthalate EC / List no: 288-646-1 | CAS no: 85851-86-1
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Isononyl isooctyl phthalate EC / List no: 306-190-4 | CAS no: 96532-79-5
1,2-Benzenedicarboxylic acid, bis(2,5-dimethylhexyl) ester EC / List no: - | CAS no: 104719-70-2
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
Isodecyl isooctyl phthalate EC / List no: 255-760-8 | CAS no: 42343-35-1
2-ethylhexyl isononyl phthalate EC / List no: 288-652-4 | CAS no: 85851-92-9
1,2-Benzenedicarboxylic acid, bis-(1-ethylhexyl) ester EC / List no: - | CAS no: 15495-94-0
2-ethylhexyl 8-methylnonyl phthalate EC / List no: 201-883-7 | CAS no: 89-13-4
-
-
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
2-ethylhexyl isononyl phthalate EC / List no: 288-652-4 | CAS no: 85851-92-9
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
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
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
1,2-Benzenedicarboxylic acid, bis(2-propylpentyl) ester EC / List no: - | CAS no: 70910-37-1
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
2-ethylhexyl octyl phthalate EC / List no: 701-508-1 | CAS no: 3461-26-5
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
2-ethylhexyl 8-methylnonyl phthalate EC / List no: 201-883-7 | CAS no: 89-13-4
Bis(1-methylheptyl) phthalate EC / List no: 205-014-2 | CAS no: 131-15-7
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Bis(2-ethylhexyl) phthalate EC / List no: 204-211-0 | CAS no: 117-81-7
Isodecyl isooctyl phthalate EC / List no: 255-760-8 | CAS no: 42343-35-1
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Isononyl isooctyl phthalate EC / List no: 306-190-4 | CAS no: 96532-79-5
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
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
Diisooctyl phthalate EC / List no: 248-523-5 | CAS no: 27554-26-3
1,2-Benzenedicarboxylic acid, bis-(1-ethylhexyl) ester EC / List no: - | CAS no: 15495-94-0
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
2-ethylhexyl nonyl phthalate EC / List no: 288-646-1 | CAS no: 85851-86-1
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
1,2-Benzenedicarboxylic acid, bis(2,5-dimethylhexyl) ester EC / List no: - | CAS no: 104719-70-2
-
-
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-methyldecyl) phthalate EC / List no: 288-643-5 | CAS no: 85851-83-8
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
Bis(2-propyloctyl) phthalate EC / List no: 288-645-6 | CAS no: 85851-85-0
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Isononyl isoundecyl phthalate EC / List no: 285-920-2 | CAS no: 85168-79-2
Diisoundecyl phthalate EC / List no: 306-165-8 | CAS no: 96507-86-7
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
Isodecyl isoundecyl phthalate EC / List no: 305-701-8 | CAS no: 94979-22-3
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
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-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Bis(2-ethylnonyl) phthalate EC / List no: 288-641-4 | CAS no: 85851-82-7
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
-
-
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
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Diisoundecyl phthalate EC / List no: 306-165-8 | CAS no: 96507-86-7
Bis(2-propyloctyl) phthalate EC / List no: 288-645-6 | CAS no: 85851-85-0
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
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
Bis(2-ethylnonyl) phthalate EC / List no: 288-641-4 | CAS no: 85851-82-7
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
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
Isononyl isoundecyl phthalate EC / List no: 285-920-2 | CAS no: 85168-79-2
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
Bis(2-methyldecyl) phthalate EC / List no: 288-643-5 | CAS no: 85851-83-8
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
-
-
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
201-607-5
85-44-9
158
23380
76320
yes
no
Details
-
-
820
76420
yes
no
Details
923-642-1
106392-12-5
551
79920
yes
no
Details
-
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
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
Details
630-556-5
124578-12-7
812
80350
yes
no
Only to be used in plastics up to 0,1 % w/w.
Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.
Details
-
1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
Details
-
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
700-107-9
87189-25-1
751
81515
yes
no
Details
606-265-4
192268-64-7
780
81220
yes
no
5 mg/kg
Details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
Details
-
-
70
76463
yes
no
Details
613-156-5
63148-62-9
575
76721
yes
no
Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).
Details
-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
Details
-
167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
Details
-
-
71
76730
yes
no
6 mg/kg
Details
608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
Details
608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
-
-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
Details
-
-
73
76866
yes
yes
Details
-
-
73
76866
yes
yes
Details
-
-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
Details
618-339-3
9002-88-4
549
80000
yes
no
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
Details
1 - 4.5 moles ethoxylated
500-038-2
25322-68-3
638
23590
76960
yes
no
Details
-
-
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
-
-
78
77897
yes
no
5 mg/kg
Details
-
-
74
77440
yes
yes
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
Details
-
-
75
77702
yes
no
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
Details
1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
Details
618-421-9
9005-66-7
570
79200
yes
no
Details

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