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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208-178-3
514-10-3
346
10030
no
no
Details
-
-
346
10030
no
no
Details
-
-
347
25540
13050
no
no
Details
208-432-3
528-44-9
347
25540
13050
no
no
Details
-
-
348
67891
22350
yes
no
Details
208-875-2
544-63-8
348
67891
22350
yes
no
Details
209-008-0
552-30-7
349
25550
no
no
Details
-
-
35
54280
yes
no
Details
-
-
350
63920
yes
no
Details
209-180-7
557-59-5
350
63920
yes
no
Details
209-249-1
563-45-1
351
21730
no
no
0.01 mg/kg
Only to be used in polypropylene.
Details
209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
Details
-
-
352
16360
no
no
0.05 mg/kg
Details
209-530-9
584-09-8
353
42480
yes
no
12 mg/kg
Details
209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
209-548-7
585-07-9
355
20170
no
no
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
209-929-8
598-32-3
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
-
-
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
209-968-0
599-64-4
358
14841
no
no
0.05 mg/kg
Details
-
-
358
14841
no
no
0.05 mg/kg
Details
210-288-1
611-99-4
359
15970
48720
yes
no
Details
-
-
36
54450
yes
no
Details
210-647-2
620-67-7
360
57920
yes
no
Details
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
-
-
361
18700
no
no
0.05 mg/kg
Details
211-128-3
630-08-0
362
14350
no
no
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
211-492-3
652-67-5
364
15404
no
no
5 mg/kg
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
Details
-
-
364
15404
no
no
5 mg/kg
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
Details
211-710-7
689-12-3
365
11680
no
no
Details
211-720-1
691-37-2
366
22150
no
no
0.05 mg/kg
Details
-
-
367
16697
no
no
Details
211-746-3
693-23-2
367
16697
no
no
Details
211-750-5
693-36-7
368
93280
yes
yes
Details
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
-
-
369
12761
no
no
0.05 mg/kg
Details
-
-
37
54480
yes
no
Details
212-084-8
760-93-0
370
21460
no
no
Details
212-454-9
818-61-1
371
11830
11510
no
no
Details
212-485-8
822-06-0
372
18640
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
Details
212-782-2
868-77-9
374
21190
no
no
Details
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
213-048-4
919-30-2
377
12786
no
no
0.05 mg/kg
Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers.
SML = 0,05 mg/kg when used for the surface treatment of materials and articles.
Details
213-086-1
923-02-4
378
21970
no
no
0.05 mg/kg
Details
213-103-2
924-42-5
379
21940
no
no
0.01 mg/kg
Details
-
-
38
55520
yes
no
Details
213-120-5
925-60-0
380
11980
no
no
Details
213-245-5
931-88-4
381
15030
no
no
0.05 mg/kg
Only to be used in polymers contacting foods for which simulant A is laid down.
Details
213-424-8
947-04-6
382
19490
no
no
5 mg/kg
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
213-663-8
999-61-1
385
11530
no
no
0.05 mg/kg
SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester.
It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).
Details
213-853-0
1034-01-1
386
55280
yes
no
Details
214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
Details
214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
Details
214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
Details
-
-
389
22360
no
no
5 mg/kg
Details
919-828-7
308066-94-6
39
55600
yes
no
Details
214-620-6
1166-52-5
390
55200
yes
no
Details
214-703-7
1187-93-5
391
22932
no
no
0.05 mg/kg
Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.
Details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
Details
A colloidal clay. Consists primarily of montmorillonite.
215-108-5
1302-78-9
393
37280
yes
no
Details
215-137-3
1305-62-0
394
41280
yes
no
Details
215-138-9
1305-78-8
395
41520
yes
no
Details
215-170-3
1309-42-8
396
64640
yes
no
Details
215-171-9
1309-48-4
397
64720
yes
no
Details
215-175-0
1309-64-4
398
35760
yes
no
Details
215-181-3
1310-58-3
399
81600
yes
no
Details
915-277-1
32052-51-0
4
22332
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
215-637-1
1335-58-6
40
56360
yes
no
Details
215-185-5
1310-73-2
400
86720
yes
no
Details
215-211-5
1313-82-2
401
24475
no
no
Details
215-222-5
1314-13-2
402
96240
yes
no
Details
215-251-3
1314-98-3
403
96320
yes
no
Details
215-263-9
1317-33-5
404
67200
yes
no
Details
215-325-5
1321-74-0
405
16690
no
no
0.01 mg/kg
SML expressed as the sum of divinylbenzene and ethylvinylbenzene.
It may contain up to 45 % (m/m) of ethylvinylbenzene
Details
215-354-3
1323-39-3
406
83300
yes
no
Details
215-540-4
1330-43-4
407
87040
yes
no
Details
215-549-3
1330-80-9
408
82960
yes
no
Details
215-570-8
1332-37-2
409
62240
yes
no
Details
-
-
41
56486
yes
no
Details
A clay that is essentially kaolinite, a hydrated aluminum silicate. It has a high fusion point and is the most refractory of all clays.
310-194-1
1332-58-7
410
62720
yes
no
Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi- layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.
Details
215-609-9
1333-86-4
411
42080
yes
no
Primary particles of 10 - 300 nm which are aggregated to a size of 100 - 1200 nm which may form agglomerates within the size distribution of 300 nm - mm.
Toluene extractables: maximum 0,1 %, determined according to ISO method 6209.
UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis.
Benzo(a)pyrene content: max 0,25 mg/kg carbon black.
Maximum use level of carbon black in the polymer: 2,5 % w/w.
Details
215-625-6
1335-23-5
412
45200
yes
no
Details
215-647-6
1336-21-6
413
35600
yes
no
Details
215-663-3
1338-39-2
414
87600
yes
no
Details
215-664-9
1338-41-6
415
87840
yes
no
Details
215-665-4
1338-43-8
416
87680
yes
no
Details
-
-
417
85680
yes
no
Details
215-683-2
1343-98-2
417
85680
yes
no
Details
215-691-6
1344-28-1
418
34720
yes
no
Details
-
-
419
92150
yes
no
According to the JECFA specifications.
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
-
-
42
56487
yes
no
Details
215-951-9
1459-93-4
420
19210
no
no
0.05 mg/kg
Details
216-032-5
1477-55-0
421
13000
no
no
Details
216-245-3
1533-45-5
422
38515
yes
yes
0.05 mg/kg
Details

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