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 26 april 2024. Database contains 1080 unique substances/entries.
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200-579-1
64-18-6
114
55040
yes
no
Details
203-743-0
110-17-8
249
55120
17290
yes
no
Details
221-800-8
3238-40-2
1031
no
no
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.
The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).
Details
-
29204-02-2
667
55190
yes
no
Details
214-620-6
1166-52-5
390
55200
yes
no
Details
213-853-0
1034-01-1
386
55280
yes
no
Details
204-498-2
121-79-9
290
55360
yes
no
Details
A complex combination of proteins obtained by hydrolysis of collagen by boiling skin, tendons, ligaments, bones, etc.
232-554-6
9000-70-8
547
55440
yes
no
Details
-
-
38
55520
yes
no
Details
919-828-7
308066-94-6
39
55600
yes
no
Details
200-075-1
50-99-7
102
17530
no
no
Details
203-817-2
110-94-1
256
18010
55680
yes
no
Details
203-593-6
108-55-4
238
18070
no
no
Details
451-530-8
736150-63-3
783
55910
yes
no
Details
200-289-5
56-81-5
103
18100
55920
yes
no
Details
-
99880-64-5
754
56020
yes
no
Details
250-097-0
30233-64-8
669
56610
yes
no
Details
-
26402-23-3
647
56720
yes
no
Details
250-379-3
30899-62-8
670
56800
yes
no
Details
247-668-1
26402-26-6
648
56880
yes
no
Details
-
-
54
57040
yes
no
Details
-
-
55
57120
yes
no
Details
-
-
56
57200
yes
no
Details
-
-
57
57280
yes
no
Details
-
-
58
57600
yes
no
Details
-
-
59
57680
yes
no
Details
242-471-7
18641-57-1
626
57800
yes
no
Details
210-647-2
620-67-7
360
57920
yes
no
Details
-
-
44
56495
yes
no
Details
215-637-1
1335-58-6
40
56360
yes
no
Details
-
-
41
56486
yes
no
Details
-
-
42
56487
yes
no
Details
-
-
43
56490
yes
no
Details
-
-
45
56500
yes
no
Details
-
-
46
56510
yes
no
Details
234-397-9
11140-02-6
47
56520
yes
no
Details
-
-
48
56535
yes
no
Details
253-407-2
37220-82-9
49
56540
yes
no
Details
234-400-3
11140-06-0
50
56550
yes
no
Details
-
-
51
56570
yes
no
Details
261-327-4
58561-47-0
52
56580
yes
no
Details
234-325-6
11099-07-3
53
56585
yes
no
Details
-
-
60
58300
yes
no
Details
201-180-5
79-14-1
794
18117
no
no
Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.
Details
231-955-3
7782-42-5
521
58320
yes
no
Details
-
-
1060
yes
no
Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E.
The seed hulls shall be obtained from sunflower seeds that are fit for human consumption.
The processing temperature of the plastic containing the additive shall not exceed 240 °C.
Details
232-536-8
9000-30-0
544
58400
yes
no
Details
232-519-5
9000-01-5
541
58480
yes
no
Details
203-838-7
111-14-8
259
58720
yes
no
Details
234-448-5
12004-14-7
598
41600
yes
no
Details
204-078-9
115-28-6
278
18250
no
no
0.01 mg/kg
Details
204-077-3
115-27-5
277
18280
no
no
0.01 mg/kg
Details
200-311-3
57-09-0
104
58960
yes
no
6 mg/kg
Details
204-127-4
116-15-4
282
18430
no
no
0.01 mg/kg
Details
212-485-8
822-06-0
372
18640
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
204-679-6
124-09-4
305
18460
15274
no
no
2.4 mg/kg
Details
202-905-8
100-97-0
196
18670
59280
yes
no
Details
205-550-7
142-62-1
329
59360
yes
no
Details
606-340-1
19569-21-2
627
59760
yes
no
Details
231-595-7
7647-01-0
507
59990
yes
no
Details
-
-
789
60027
yes
no
Average molecular weight not less than 440 Da.
Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).
Details
811-989-0
12072-90-1
600
60030
yes
no
Details
602-916-1
12304-65-3
604
60080
yes
no
Details
618-410-9
9005-27-0
565
61120
yes
no
Details
618-387-5
9004-62-0
558
60560
yes
no
Details
618-528-0
9032-42-2
576
60880
yes
no
Details
609-415-7
37353-59-6
686
61390
yes
no
Details
618-565-2
9049-76-7
579
61800
yes
no
Details
618-388-0
9004-64-2
559
61680
yes
no
Details
228-601-5
6303-21-5
494
62140
yes
no
Details
215-570-8
1332-37-2
409
62240
yes
no
Details
235-798-1
12751-22-3
607
62245
yes
no
Only to be used in PET polymers and copolymers
Details
200-857-2
75-28-5
1069
yes
no
Only to be used as a blowing agent.
Details
204-066-3
115-11-7
276
19000
no
no
Details
203-678-8
109-53-5
243
19060
no
no
0.05 mg/kg
Details
695-178-5
9044-17-1
577
62280
yes
no
Details
201-142-8
78-78-4
143
62450
yes
no
Details
204-506-4
121-91-5
291
19150
no
no
Details
202-774-7
99-63-8
188
19180
no
no
Details
215-951-9
1459-93-4
420
19210
no
no
0.05 mg/kg
Details
202-599-6
97-65-4
182
19270
no
no
Details
-
8001-39-6
525
62640
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
The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.
296-473-8
92704-41-1
753
62800
yes
no
Details
201-766-0
87-69-4
161
92160
yes
no
Details
200-018-0
50-21-5
99
19460
62960
yes
no
Details
205-316-4
138-22-7
322
63040
yes
no
Details
205-582-1
143-07-7
330
63280
19470
yes
no
Details
218-414-7
2146-71-6
436
19480
no
no
Details
213-424-8
947-04-6
382
19490
no
no
5 mg/kg
Details
The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.
232-307-2
8002-43-5
528
63760
yes
no
Details
204-649-2
123-76-2
299
63840
yes
no
Details
234-384-8
11132-73-3
595
19510
no
no
Details
209-180-7
557-59-5
350
63920
yes
no
Details
617-129-9
8062-15-5
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
200-470-9
60-33-3
112
64015
yes
no
Details
217-792-0
28290-79-1
663
64150
yes
no
Details
233-822-5
10377-51-2
588
64320
yes
no
Details
-
-
62
64500
yes
no
Details
203-577-9
108-39-4
235
14710
no
no
Details
215-170-3
1309-42-8
396
64640
yes
no
Details
215-171-9
1309-48-4
397
64720
yes
no
Details
203-742-5
110-16-7
248
19540
64800
yes
no
Details
203-571-6
108-31-6
234
19960
no
no
Details
607-789-6
25736-61-2
642
64990
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,05 % (w/w).
Details
230-022-8
6915-15-7
499
19965
65020
yes
no
In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.
Details
205-503-0
141-82-2
328
65040
yes
no
Details
231-869-6
7773-01-5
520
65120
yes
no
Details
882-488-2
12626-88-9
606
65200
yes
no
Details
233-143-4
10043-84-2
586
65280
yes
no
Details
234-378-5
11129-60-5
594
65360
yes
no
Details
-
-
63
65440
yes
no
Details
201-770-2
87-78-5
162
65520
yes
no
Details
201-202-3
79-39-0
149
19990
no
no
0.01 mg/kg
Details
201-204-4
79-41-4
150
20020
no
no
Details
203-441-9
106-91-2
220
20590
no
no
0.02 mg/kg
Details
220-688-8
2867-47-2
455
20530
no
no
0.01 mg/kg
Details
234-207-4
10595-80-9
590
21370
no
no
0.01 mg/kg
Details
202-473-0
96-05-9
175
20050
no
no
0.05 mg/kg
Details
219-674-4
2495-37-6
447
20080
no
no
Details
202-615-1
97-88-1
184
20110
no
no
Details
202-943-5
101-43-9
197
20260
no
no
0.05 mg/kg
Details
218-218-1
2082-81-7
434
20410
no
no
0.05 mg/kg
Details
202-617-2
97-90-5
185
20440
no
no
0.05 mg/kg
Details
202-597-5
97-63-2
181
20890
no
no
Details
202-613-0
97-86-9
183
21010
no
no
Details
225-094-2
4655-34-9
482
21100
no
no
Details
201-297-1
80-62-6
156
21130
no
no
Details
212-782-2
868-77-9
374
21190
no
no
Details
218-542-3
2177-70-0
439
21280
no
no
Details
218-639-0
2210-28-8
440
21340
no
no
Details
221-073-7
2998-18-7
457
20140
no
no
Details
-
54276-35-6
694
21400
no
no
0.05 mg/kg
Details
209-548-7
585-07-9
355
20170
no
no
Details
212-084-8
760-93-0
370
21460
no
no
Details
204-817-5
126-98-7
312
21490
no
no
0.01 mg/kg
Details
-
-
818
21530
no
no
5 mg/kg
Details
200-659-6
67-56-1
117
21550
no
no
Details
-
37206-01-2
683
66200
yes
no
Details
618-391-7
9004-67-5
561
66240
yes
no
Details
-
9004-59-5
557
66640
yes
no
Details
-
-
64
66695
yes
no
Details
618-389-6
9004-65-3
560
66700
yes
no
Details
614-610-5
68554-70-1
730
66930
yes
no
Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.
Details
601-648-2
12001-26-2
597
67120
yes
no
Details
-
-
1062
no
no
Only to be used for the production of recycled PET and at up to 0,12 % (w/w).
Details
247-063-2
25513-64-8
641
22331
no
no
0.05 mg/kg
Details
915-277-1
32052-51-0
4
22332
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
-
-
65
67155
yes
no
Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation).
Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %)
Details
288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
Details
215-263-9
1317-33-5
404
67200
yes
no
Details
266-836-5
67649-65-4
720
67360
yes
no
Details
248-227-6
27107-89-7
657
67680
yes
no
Details
-
-
66
67600
yes
no
Details
247-665-5
26401-86-5
645
67760
yes
no
Details
260-828-5
57583-34-3
697
67515
yes
no
Details
259-374-0
54849-38-6
695
67520
yes
no
Details
Wax obtained by extraction of lignite.
232-313-5
8002-53-7
529
67850
yes
no
Details
-
-
67
67840
yes
no
Details
-
-
1030
yes
no
0.05 mg/kg
Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below.
The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food.
Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
Details
-
-
1075
yes
no
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
Details
208-875-2
544-63-8
348
67891
22350
yes
no
Details
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
791
92470
yes
no
0.05 mg/kg
Details
481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
Details
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
Details
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
795
40155
yes
no
0.05 mg/kg
Details
-
61269-61-2
701
40160
yes
no
2.4 mg/kg
Details
251-156-3
32687-78-8
675
38800
yes
yes
15 mg/kg
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
-
153250-52-3
772
47500
yes
no
5 mg/kg
Details
203-004-2
102-08-9
200
51680
yes
yes
3 mg/kg
Details
237-457-2
13811-50-2
612
16694
no
no
0.05 mg/kg
Details
203-756-1
110-31-6
251
53360
yes
no
Details
226-864-0
5518-18-3
488
53440
yes
no
Details
203-755-6
110-30-5
250
53520
yes
no
Details
203-041-4
102-60-3
204
92640
25180
yes
no
Details
-
-
19
39090
yes
no
Details
-
-
20
39120
yes
no
SML(T) expressed excluding HCl.
Details
204-393-1
120-40-1
923
39150
yes
no
5 mg/kg
The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, shall not result in a migration of diethanolamine higher than 0,3 mg/kg food.
Details
-
-
1081
yes
no
Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III.
Details
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
282-811-1
84434-12-8
748
12765
no
no
0.05 mg/kg
Details
203-867-5
111-41-1
262
35284
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
203-157-5
103-90-2
208
18898
no
no
0.05 mg/kg
Details
-
-
14
33801
yes
no
30 mg/kg
Details
206-376-4
334-48-5
336
45940
15095
yes
no
Details
211-746-3
693-23-2
367
16697
no
no
Details
271-487-7
68564-88-5
731
18220
no
no
0.05 mg/kg
Details
-
66822-60-4
719
65920
yes
no
Details
213-103-2
924-42-5
379
21940
no
no
0.01 mg/kg
Details
213-086-1
923-02-4
378
21970
no
no
0.05 mg/kg
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
225-218-5
4724-48-5
483
68860
yes
no
0.05 mg/kg
Details
221-698-5
3195-78-6
462
26170
no
no
0.02 mg/kg
Details
248-093-9
26896-20-8
819
68110
yes
no
0.05 mg/kg
Not to be used in polymers contacting fatty foods.
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
SML expressed as neodecanoic acid.
Details
-
-
810
68119
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
-
-
810
68119
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
609-369-8
37244-96-5
684
68125
yes
no
Details
618-392-2
9004-70-0
562
22450
no
no
Details
202-423-8
95-48-7
174
14740
no
no
Details

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