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 23 April 2024. Database contains 1080 unique substances/entries.
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204-872-5
127-91-3
314
23500
no
no
Details
231-493-2
7585-39-9
503
46080
yes
no
Details
201-291-9
80-56-8
155
23470
no
no
Details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
Details
641-029-4
156065-00-8
874
16265
no
no
0.05 mg/kg
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
641-029-4
156065-00-8
874
16265
no
no
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
233-007-4
10016-20-3
580
46070
yes
no
Details
604-838-3
152261-33-1
803
33535
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Not to be used in contact with alcoholic foods.
Details
215-251-3
1314-98-3
403
96320
yes
no
Details
215-222-5
1314-13-2
402
96240
yes
no
Details
215-222-5
1314-13-2
1046
yes
no
Only to be used in unplasticised polymers.
The restrictions and specifications specified for FCM substance No 788 shall be respected.
Details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
Details
243-814-3
20427-58-1
628
96190
yes
no
Details
234-394-2
11138-66-2
596
95935
yes
no
Details
237-772-5
13983-17-0
613
95905
yes
no
Details
-
-
95
95883
yes
no
Average molecular weight not less than 480 Da.
Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
Details
-
-
94
95859
yes
no
Average molecular weight not less than 500 Da.
Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
Details
-
-
93
95858
yes
no
0.05 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).
Details
231-791-2
7732-18-5
515
95855
26360
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
Details
220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
Details
201-081-7
78-08-0
142
26305
no
no
0.05 mg/kg
Only to be used as a surface treatment agent.
Details
200-867-7
75-38-7
132
26140
no
no
5 mg/kg
Details
200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
MICROLITE (R) POWDER; MICROLITE (R) VERMICULITE DISPERSIONS; MICROLITE POWDER; MICROLITE SPECIALITY VERMICULITE; MICROLITE VERMICULITE DISPERSIONS; MICROLITE-VERMICULITDISPERSIONEN
406-060-8
110638-71-6
757
95725
yes
no
Details
200-315-5
57-13-6
107
25960
no
no
Details
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
Details
222-020-0
3319-31-1
1078
yes
no
1 mg/kg
Only to be used as plasticiser to manufacture soft poly(vinyl chloride).
Not to be used in contact with foods intended for infants.
Details
246-466-0
24800-44-0
634
25910
no
no
Details
203-812-5
110-88-3
255
25900
no
no
5 mg/kg
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
-
-
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
927-697-2
28931-67-1
664
95000
yes
no
Details
219-547-3
2459-10-1
971
25885
no
no
Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.
Details
209-008-0
552-30-7
349
25550
no
no
Details
208-432-3
528-44-9
347
25540
13050
no
no
Details
204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
Details
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
Details
203-953-2
112-27-6
266
25510
94320
yes
no
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
203-049-8
102-71-6
793
94000
yes
no
Details
-
-
92
93970
yes
no
0.05 mg/kg
Details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
Details
203-048-2
102-70-5
205
25385
no
no
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.
Only to be used in hydrogels intended for non-direct food contact use.
Details
-
-
5
25360
no
no
0.01 mg/kg
1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
-
-
6
25380
no
no
0.05 mg/kg
Details
201-067-0
77-90-7
138
93760
yes
no
Details
232-552-5
9000-65-1
545
93680
yes
no
Details
231-710-0
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
247-117-5
25583-20-4
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
234-354-4
11116-16-8
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
-
-
805
93450
yes
no
The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w.
Details
-
-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
Details
-
-
873
93460
yes
no
Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
Details
236-675-5
13463-67-7
610
93440
yes
no
Details
240-613-2
16545-54-3
894
93360
yes
no
Details
211-750-5
693-36-7
368
93280
yes
yes
Details
204-614-1
123-28-4
294
93120
yes
yes
Details
SYNESAL M
404-440-8
120218-34-0
761
92930
yes
no
6 mg/kg
Details
255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
Details
254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
Details
203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
Details
204-126-9
116-14-3
281
25120
no
no
0.05 mg/kg
Details
203-989-9
112-60-7
269
92350
25090
yes
no
Details
-
-
91
92320
yes
yes
15 mg/kg
Details
246-563-8
25013-16-5
635
40720
yes
no
30 mg/kg
Details
204-411-8
120-61-6
288
24970
no
no
Details
260-815-4
57569-40-1
696
92205
yes
no
Details
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
Details
229-176-9
6422-86-2
798
92200
yes
no
Details
202-829-5
100-20-9
191
24940
no
no
Details
202-830-0
100-21-0
785
24910
no
no
Details
-
-
90
92195
yes
no
Details
Gallic acid derivatives found in nutgalls, bark and other plant parts, especially oak bark.
215-753-2
1401-55-4
419
92150
yes
no
According to the JECFA specifications.
Details
238-877-9
14807-96-6
615
92080
yes
no
Details
270-337-8
68425-17-2
724
24903
no
no
In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].
Details
231-639-5
7664-93-9
511
91920
yes
no
Details
231-722-6
7704-34-9
514
91840
yes
no
Details
-
-
814
91815
yes
no
2 mg/kg
Details
-
-
813
91530
yes
no
5 mg/kg
Details
204-772-1
126-14-7
309
91360
yes
no
Details
204-771-6
126-13-6
308
91200
yes
no
Details
200-334-9
57-50-1
108
24880
no
no
Details
203-570-0
108-30-5
233
24850
no
no
Details
203-740-4
110-15-6
247
90960
24820
yes
no
Details
248-104-7
26914-43-2
656
24760
no
no
0.05 mg/kg
Details
843-371-1
25101-28-4
856
40563
yes
no
Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
Details
202-851-5
100-42-5
193
24610
no
no
Details
261-257-4
58446-52-9
699
90720
yes
no
Details
-
-
821
90810
yes
no
Details
-
-
89
89440
yes
no
Details
204-666-5
123-95-5
301
89120
yes
no
Details
200-313-4
57-11-4
106
24550
89040
yes
no
Details
204-693-2
124-26-5
306
88960
yes
no
Details
686-629-7
68412-29-3
723
88880
yes
no
Details
High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.
232-679-6
9005-25-8
564
24540
88800
yes
no
Details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
232-391-0
8013-07-8
532
88640
yes
no
Details
232-391-0
8013-07-8
532
88640
yes
no
30 mg/kg
In the case of PVC gaskets used to seal glass jars containing 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, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).
232-274-4
8001-22-7
524
24520
no
no
Details
248-027-9
26836-47-5
654
88600
yes
no
Details
200-061-5
50-70-4
100
88320
24490
yes
no
Details
247-891-4
26658-19-5
651
88240
yes
no
Details
258-994-9
54140-20-4
693
88160
yes
no
Details
247-569-3
26266-58-0
644
88080
yes
no
Details
262-958-8
61752-68-9
702
87920
yes
no
Details
215-664-9
1338-41-6
415
87840
yes
no
Details
247-568-8
26266-57-9
643
87760
yes
no
Details
215-665-4
1338-43-8
416
87680
yes
no
Details
215-663-3
1338-39-2
414
87600
yes
no
Details
263-600-3
62568-11-0
709
87520
yes
no
Details
249-448-0
29116-98-1
666
87280
yes
no
Details
203-768-7
110-44-1
252
87200
yes
no
Details
231-867-5
7772-98-7
519
87120
yes
no
Details
215-540-4
1330-43-4
407
87040
yes
no
Details
231-821-4
7757-83-7
516
86960
yes
no
Details
215-211-5
1313-82-2
401
24475
no
no
Details
231-555-9
7632-00-0
506
86920
yes
no
0.6 mg/kg
Details
-
-
88
86880
yes
no
9 mg/kg
Details
231-679-3
7681-82-5
513
86800
yes
no
Details
215-185-5
1310-73-2
400
86720
yes
no
Details
231-599-9
7647-15-6
508
86560
yes
no
Details
231-548-0
7631-90-5
505
86480
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
231-545-4
7631-86-9
504
86240
yes
no
For synthetic amorphous silicon dioxide: primary particles of 1 - 100 nm which are aggregated to a size of 0,1 - 1 µm which may form agglomerates within the size distribution of 0,3 µm to the mm size.
Details
206-991-8
409-21-2
339
86160
yes
no
Details
-
-
86
86000
yes
no
Details
215-683-2
1343-98-2
417
85680
yes
no
Details
-
-
85
85610
yes
no
Details
-
-
84
85601
yes
no
Details
219-882-5
2561-88-8
450
24430
no
no
Details
203-672-5
109-43-3
242
85360
yes
no
Details
203-845-5
111-20-6
260
24280
no
no
Details
204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
232-689-0
9006-04-6
574
84560
24250
yes
no
Details
264-848-5
64365-17-9
714
84400
yes
no
Details
232-476-2
8050-15-5
536
84320
yes
no
Details
266-042-9
65997-13-9
718
84240
yes
no
Details
266-041-3
65997-06-0
717
84210
yes
no
Details
232-479-9
8050-26-8
537
84080
yes
no
Details
232-482-5
8050-31-5
538
84000
yes
no
Details
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
539
24160
no
no
Details
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
535
24100
24190
83840
24130
yes
no
Details
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
Details
202-987-5
101-90-6
199
24073
no
no
0.01 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
For indirect food contact only, behind a PET layer.
Details
277-299-1
73138-82-6
741
83610
24070
yes
no
Details
270-476-4
68442-12-6
726
83599
yes
yes
Details
432-130-2
119345-01-6
760
83595
yes
no
18 mg/kg
Composition: 4,4'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)),4,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)),3,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)),4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)),tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)),4,4'-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))(*)Quantity of substance used/quantity of formulationOther specifications: Phosphor content of min. 5,4 % to max. 5,9 %,Acid value of max. 10 mg KOH per gram,Melt range of 85- 110 °C.
Details
238-878-4
14808-60-7
616
83470
yes
no
Details
602-803-7
12269-78-2
603
83460
yes
no
Details
-
13445-56-2
609
83455
yes
no
Details
219-574-0
2466-09-3
445
83440
yes
no
Details
201-898-9
89-32-7
166
24057
no
no
0.05 mg/kg
Details
-
-
83
83330
yes
no
Details
-
-
82
83325
yes
no
Details
-
-
81
83320
yes
no
Details
200-879-2
75-56-9
135
24010
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
204-062-1
115-07-1
275
23980
no
no
Details
204-638-2
123-62-6
297
23950
no
no
Details
203-293-5
105-38-4
211
23920
no
no
Details
201-176-3
79-09-4
146
82000
23890
yes
no
Details
204-623-0
123-38-6
296
23860
no
no
Details
-
-
80
81760
yes
no
Details
231-659-4
7681-11-0
512
81680
yes
no
Details
215-181-3
1310-58-3
399
81600
yes
no
Details
231-830-3
7758-02-3
517
81520
yes
no
Details
618-363-4
9003-39-8
552
81500
yes
no
The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC [OJ L 253, 20.9.2008, p. 1.].
Details
1 - 4.5 moles propoxylated
500-039-8
25322-69-4
639
23651
80800
yes
no
Details
618-352-4
9003-07-0
550
81060
yes
no
Details
232-417-0
8017-16-1
534
80720
yes
no
Details
-
-
79
80640
yes
no
Details
608-428-5
29894-35-7
668
80240
yes
no
Details
607-759-2
25618-55-7
1017
yes
no
To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
Details
680-598-3
70142-34-6
737
77370
yes
no
Details
618-558-4
9046-01-9
578
79600
yes
no
5 mg/kg
For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
Details
618-424-5
9005-71-4
573
79440
yes
no
Details
618-422-4
9005-70-3
572
79360
yes
no
Details
1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
Details
618-421-9
9005-66-7
570
79200
yes
no
Details
1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
Details
1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
-
-
75
77702
yes
no
Details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
-
-
74
77440
yes
yes
42 mg/kg
Details
-
-
78
77897
yes
no
5 mg/kg
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
-
-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
Details
1 - 4.5 moles ethoxylated
500-038-2
25322-68-3
638
23590
76960
yes
no
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
Details
618-339-3
9002-88-4
549
80000
yes
no
Details
-
-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
Details
-
-
73
76866
yes
yes
Details
-
-
73
76866
yes
yes
Details
-
-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 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

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