plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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 15 October 2021. Database contains 1072 unique substances/entries.
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217-168-8
1761-71-3
429
13210
no
no
0.05 mg/kg
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216-971-0
1709-70-2
428
95200
yes
no
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216-847-6
1679-51-2
427
18896
no
no
0.05 mg/kg
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216-823-5
1675-54-3
426
13610
13510
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
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216-768-7
1663-39-4
425
10840
no
no
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216-711-6
1647-16-1
424
15070
no
no
0.05 mg/kg
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216-600-2
1623-05-8
423
22937
no
no
0.05 mg/kg
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216-245-3
1533-45-5
422
38515
yes
yes
0.05 mg/kg
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216-032-5
1477-55-0
421
13000
no
no
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215-951-9
1459-93-4
420
19210
no
no
0.05 mg/kg
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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.
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215-691-6
1344-28-1
418
34720
yes
no
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215-683-2
1343-98-2
417
85680
yes
no
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215-665-4
1338-43-8
416
87680
yes
no
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215-664-9
1338-41-6
415
87840
yes
no
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215-663-3
1338-39-2
414
87600
yes
no
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215-647-6
1336-21-6
413
35600
yes
no
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215-637-1
1335-58-6
40
56360
yes
no
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215-625-6
1335-23-5
412
45200
yes
no
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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.
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215-570-8
1332-37-2
409
62240
yes
no
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215-549-3
1330-80-9
408
82960
yes
no
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215-540-4
1330-43-4
407
87040
yes
no
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215-354-3
1323-39-3
406
83300
yes
no
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215-263-9
1317-33-5
404
67200
yes
no
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215-251-3
1314-98-3
403
96320
yes
no
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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.
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215-222-5
1314-13-2
402
96240
yes
no
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215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
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215-211-5
1313-82-2
401
24475
no
no
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215-185-5
1310-73-2
400
86720
yes
no
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215-181-3
1310-58-3
399
81600
yes
no
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215-175-0
1309-64-4
398
35760
yes
no
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215-171-9
1309-48-4
397
64720
yes
no
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215-170-3
1309-42-8
396
64640
yes
no
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215-138-9
1305-78-8
395
41520
yes
no
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215-137-3
1305-62-0
394
41280
yes
no
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A colloidal clay. Consists primarily of montmorillonite.
215-108-5
1302-78-9
393
37280
yes
no
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214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
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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.
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214-620-6
1166-52-5
390
55200
yes
no
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214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
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214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
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214-068-6
1076-97-7
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
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214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
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213-853-0
1034-01-1
386
55280
yes
no
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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).
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213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
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213-551-9
976-56-7
1007
no
no
Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET).
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213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
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