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 17 June 2021. Database contains 1072 unique substances/entries.
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238-877-9
14807-96-6
615
92080
yes
no
Details
216-032-5
1477-55-0
421
13000
no
no
Details
-
147398-31-0
1059
no
no
Only to be used either alone or blended with other polymers in contact with all foods under contact conditions of up to 6 months and/or 6 months and more, at room temperature or below, including hot fill or a short heating up phase.
The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food.
Details
CG 30-1577
411-380-6
147315-50-2
770
51700
yes
no
0.05 mg/kg
Details
604-520-4
146340-15-0
802
33105
yes
no
5 mg/kg
Details
215-951-9
1459-93-4
420
19210
no
no
0.05 mg/kg
Details
416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
485-230-3
1455-42-1
1052
no
no
5 mg/kg
Only to be used as a monomer in the production of polyesters.
The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).
Details
238-455-4
14464-46-1
614
45560
yes
no
Details
205-634-3
144-62-7
333
69920
22775
yes
no
6 mg/kg
Details
418-370-0
143925-92-2
768
34850
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.
Details
205-597-3
143-28-2
332
69760
yes
no
Details
205-583-7
143-08-8
331
22480
no
no
Details
205-582-1
143-07-7
330
19470
63280
yes
no
Details
205-550-7
142-62-1
329
59360
yes
no
Details
205-503-0
141-82-2
328
65040
yes
no
Details
205-500-4
141-78-6
327
30140
yes
no
Details
205-483-3
141-43-5
326
35170
12763
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.
For indirect food contact only, behind a PET layer.
Details
205-480-7
141-32-2
325
10780
no
no
Details
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
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
205-438-8
140-88-5
323
11470
no
no
Details
237-772-5
13983-17-0
613
95905
yes
no
Details
237-457-2
13811-50-2
612
16694
no
no
0.05 mg/kg
Details
205-316-4
138-22-7
322
63040
yes
no
Details
205-305-4
137-66-6
321
36080
yes
no
Details
500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
Details
205-252-7
136-60-7
320
37680
yes
no
Details
413-110-2
135861-56-2
766
38879
yes
no
Details
236-946-8
13560-49-1
611
35120
yes
no
Details
411-220-5
134701-20-5
765
49485
yes
yes
1 mg/kg
Details
236-675-5
13463-67-7
610
93440
yes
no
Details
-
13445-56-2
609
83455
yes
no
Details
215-691-6
1344-28-1
418
34720
yes
no
Details
215-683-2
1343-98-2
417
85680
yes
no
Details
215-665-4
1338-43-8
416
87680
yes
no
Details
215-664-9
1338-41-6
415
87840
yes
no
Details
215-663-3
1338-39-2
414
87600
yes
no
Details
215-647-6
1336-21-6
413
35600
yes
no
Details
215-637-1
1335-58-6
40
56360
yes
no
Details
215-625-6
1335-23-5
412
45200
yes
no
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
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
215-570-8
1332-37-2
409
62240
yes
no
Details
215-549-3
1330-80-9
408
82960
yes
no
Details
215-540-4
1330-43-4
407
87040
yes
no
Details
236-236-8
13252-13-6
861
71990
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.
Details
-
132459-54-2
764
13317
no
no
0.05 mg/kg
Purity > 98,1 % (w/w).
Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).
Details
215-354-3
1323-39-3
406
83300
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

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