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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249-079-5
28553-12-0
728
75100
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
247-977-1
26761-40-0
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for 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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
247-977-1
26761-40-0
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for 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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
203-872-2
111-46-6
263
47680
13326
15760
yes
no
Details
207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
Details
-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
251-136-4
32647-67-9
674
46480
yes
no
Details
272-489-0
68855-54-9
734
46380
yes
no
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
248-468-7
27458-90-8
660
47540
yes
yes
0.05 mg/kg
Details
-
-
33
51120
yes
no
Details
239-581-2
15535-79-2
618
51040
yes
no
Details
260-414-4
56875-68-4
736
50960
yes
no
Details
-
-
32
50880
yes
no
Details
-
-
31
50800
yes
no
Details
239-625-0
15571-60-5
620
50720
yes
no
Details
222-883-3
3648-18-8
466
50640
yes
no
Details
-
-
28
50160
yes
no
Details
247-666-0
26401-97-8
646
50480
yes
no
Details
251-576-7
33568-99-9
676
50400
yes
no
Details
268-500-3
68109-88-6
29
50360
yes
no
Details
239-622-4
15571-58-1
619
50320
yes
no
Details
233-117-2
10039-33-5
582
50240
yes
no
Details
-
69226-46-6
30
50560
yes
no
Details
281-837-0
84030-61-5
747
47600
yes
yes
Details
611-185-8
54686-97-4
752
39890
yes
no
Details
Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Shorea, Dipterocarpaceae).
232-528-4
9000-16-2
543
45920
yes
no
Details
203-629-0
108-91-8
240
45760
yes
no
Details
-
263244-54-8
885
45676
yes
no
Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.
Details
223-077-4
3724-65-0
467
45600
14800
yes
no
Details
238-455-4
14464-46-1
614
45560
yes
no
Details
-
-
25
45440
yes
no
12 mg/kg
Details
-
-
24
45280
yes
no
Details
215-625-6
1335-23-5
412
45200
yes
no
Details
235-285-2
12158-74-6
972
45197
yes
no
Details
232-131-6
7787-70-4
523
45195
yes
no
Details
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
685
85950
yes
no
0.15 mg/kg
SML expressed as fluoride.
Only to be used in layers of multi-layer materials not coming into direct contact with food.
Details
234-334-5
11104-61-3
593
44960
yes
no
Details
201-070-7
77-93-0
140
44640
yes
no
Details
201-069-1
77-92-9
139
44160
14680
yes
no
Details
-
-
817
38507
yes
no
5 mg/kg
Not to be used with polyethylene in contact with acidic foods.
Purity ≥ 96 %.
Details
-
10436-08-5
589
52645
yes
no
Details
-
-
816
45704
yes
no
5 mg/kg
Details
200-871-9
75-45-6
134
43680
yes
no
6 mg/kg
Content of chlorofluoromethane less than 1 mg/kg of the substance.
Details
-
-
23
43515
yes
no
0.9 mg/kg
Details
264-846-4
64365-11-3
713
43480
yes
no
Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).
Details
A complex combination of hydrocarbons produced by the purification of ozocerite with sulfuric acid and filtration through bone black to form waxy cakes.
232-290-1
8001-75-0
526
43440
yes
no
Details
The product obtained by treating cellulose with caustic soda, reacting this with carbon disulfide, dissolving this in a dilute alkali solution and extruding into an acid to form a continuous viscose tube.
270-493-7
68442-85-3
727
43360
yes
no
Details
618-381-2
9004-36-8
554
43300
yes
no
Details
232-674-9
9004-34-6
553
43280
14500
yes
no
Details
-
-
22
43200
yes
no
Details
264-705-7
64147-40-6
712
42960
yes
no
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic. (Ricinus communis, Euphorbiaceae).
232-293-8
8001-79-4
527
42880
14411
yes
no
Details
A complex combination produced in mammary tissue from amino acids supplied by the blood. It contains several proteins, phosphorus, and calcium
232-555-1
9000-71-9
548
42800
yes
no
Details
The wax derived from Copernicia cerifera, Palmae.
232-399-4
8015-86-9
533
42720
yes
no
Details
618-326-2
9000-11-7
542
42640
yes
no
Details
-
-
21
42500
yes
no
Details
209-530-9
584-09-8
353
42480
yes
no
12 mg/kg
Details
204-696-9
124-38-9
307
42160
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
231-153-3
7440-44-0
713
43480
yes
no
Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).
Details
204-677-5
124-07-2
304
14320
41960
yes
no
Details
203-313-2
105-60-2
212
41840
14200
yes
no
Details
The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.
232-347-0
8006-44-8
530
41760
yes
no
Details
200-945-0
76-22-2
136
41680
yes
no
Details
215-138-9
1305-78-8
395
41520
yes
no
Details
215-137-3
1305-62-0
394
41280
yes
no
Details
233-140-8
10043-52-4
585
41120
yes
no
Details
227-265-7
5743-36-2
489
41040
yes
no
Details
203-448-7
106-97-8
221
40570
yes
no
Details
233-136-6
10043-11-5
583
40400
yes
no
Details
233-139-2
10043-35-3
584
40320
13620
yes
no
Details
614-830-1
68951-50-8
735
40120
yes
no
0.6 mg/kg
Details
-
69158-41-4
752
39890
yes
no
Details
CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
402-950-5
87826-41-3
752
39890
yes
no
Details
618-128-6
882073-43-0
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
NC-4
406-176-9
79072-96-1
743
38950
yes
no
Details
413-110-2
135861-56-2
766
38879
yes
no
Details
228-253-4
6200-40-4
493
39200
yes
no
1.8 mg/kg
Details
283-829-2
84731-70-4
1079
yes
no
0.05 mg/kg
Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.
Details
264-122-8
63397-60-4
710
38700
yes
yes
18 mg/kg
Details
ADK STAB PEP-36
410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
421-920-2
154862-43-8
773
38840
yes
yes
5 mg/kg
SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol).
Details
247-952-5
26741-53-7
652
38820
yes
yes
0.6 mg/kg
Details
204-337-6
119-61-9
286
38240
yes
yes
0.6 mg/kg
Details
219-020-8
2315-68-6
441
38160
yes
no
Details
202-259-7
93-58-3
171
38080
yes
no
Details
202-284-3
93-89-0
172
37840
yes
no
Details
205-252-7
136-60-7
320
37680
yes
no
Details
200-618-2
65-85-0
116
37600
13090
yes
no
Details
202-860-4
100-52-7
195
37360
yes
no
Details
A colloidal clay. Consists primarily of montmorillonite.
215-108-5
1302-78-9
393
37280
yes
no
Details
204-010-8
112-85-6
272
37040
yes
no
Details
221-304-1
3061-75-4
458
36960
yes
no
Details
The wax obtained from the honeycomb of the bee. It consists primarily of myricyl palmitate, cerotic acid and esters and some high-carbon paraffins.
232-383-7
8012-89-3
531
36880
yes
no
Details
-
12007-55-5
599
36840
yes
no
Details
233-020-5
10022-31-8
581
36800
yes
no
Details
241-234-5
17194-00-2
625
36720
yes
no
Details
234-231-5
10605-09-1
591
36160
yes
no
Details
205-305-4
137-66-6
321
36080
yes
no
Details
200-066-2
50-81-7
101
36000
yes
no
Details
-
7771-44-0
518
35845
yes
no
Details
208-031-3
506-30-9
345
35840
yes
no
Details
215-175-0
1309-64-4
398
35760
yes
no
Details
215-647-6
1336-21-6
413
35600
yes
no
Details
235-183-8
12124-97-9
601
35440
yes
no
Details
231-635-3
7664-41-7
510
12789
35320
yes
no
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
609-389-7
37293-22-4
598
41600
yes
no
Details
215-691-6
1344-28-1
418
34720
yes
no
Details
234-319-3
11097-59-9
592
34690
yes
no
Details
430-650-4
151841-65-5
771
34650
yes
no
5 mg/kg
Details
244-492-7
21645-51-2
629
34560
yes
no
Details
-
-
501
34480
yes
no
Details
-
191427-79-9
18
34475
yes
no
Details
200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
200-412-2
59-02-9
110
93520
yes
no
Details
-
-
110
93520
yes
no
Details
-
-
266
25510
94320
yes
no
Details
-
-
269
92350
25090
yes
no
Details
-
-
419
92150
yes
no
According to the JECFA specifications.
Details
-
-
511
91920
yes
no
Details
-
-
247
90960
24820
yes
no
Details
-
-
106
24550
89040
yes
no
Details
-
-
100
88320
24490
yes
no
Details
-
-
252
87200
yes
no
Details
-
-
417
85680
yes
no
Details
-
-
324
83700
yes
yes
42 mg/kg
Details
-
-
609
83455
yes
no
Details
-
-
445
83440
yes
no
Details
-
-
146
82000
23890
yes
no
Details
-
-
534
80720
yes
no
Details
-
-
509
23170
72640
yes
no
Details
-
-
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
-
-
279
22840
71600
yes
no
Details
-
-
338
71020
yes
no
Details
-
-
105
22780
70400
yes
no
Details
-
-
333
22775
69920
yes
no
6 mg/kg
Details
-
-
332
69760
yes
no
Details
-
-
270
22763
69040
yes
no
Details
-
-
483
68860
yes
no
0.05 mg/kg
Details
-
-
336
45940
15095
yes
no
Details
-
-
348
67891
22350
yes
no
Details
-
-
162
65520
yes
no
Details
-
-
328
65040
yes
no
Details
-
-
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
-
-
248
19540
64800
yes
no
Details
-
-
663
64150
yes
no
Details
-
-
112
64015
yes
no
Details
-
-
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
-
-
350
63920
yes
no
Details
-
-
299
63840
yes
no
Details
-
-
330
63280
19470
yes
no
Details
-
-
99
19460
62960
yes
no
Details
-
-
161
92160
yes
no
Details
-
-
494
62140
yes
no
Details
-
-
507
59990
yes
no
Details
-
-
329
59360
yes
no
Details
-
-
259
58720
yes
no
Details
-
-
103
18100
55920
yes
no
Details
-
-
256
18010
55680
yes
no
Details
-
-
667
55190
yes
no
Details
-
-
249
55120
17290
yes
no
Details
-
-
114
55040
yes
no
Details
-
-
227
53650
16990
yes
no
Details
-
-
111
53600
yes
no
Details
-
-
113
52800
16780
yes
no
Details
-
-
273
52730
yes
no
Details
-
-
658
52000
yes
no
30 mg/kg
Details
-
-
257
16660
13550
51760
yes
no
Details
-
-
311
51200
16480
yes
no
Details
-
-
263
13326
15760
yes
no
Details
-
-
752
39890
yes
no
Details
-
-
467
45600
14800
yes
no
Details
-
-
139
44160
14680
yes
no
Details
-
-
304
14320
41960
yes
no
Details
-
-
584
40320
13620
yes
no
Details
-
-
752
39890
yes
no
Details
-
-
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
-
-
743
38950
yes
no
Details
-
-
766
38879
yes
no
Details
-
-
116
37600
13090
yes
no
Details
-
-
272
37040
yes
no
Details
-
-
101
36000
yes
no
Details
-
-
518
35845
yes
no
Details
-
-
345
35840
yes
no
Details
-
-
566
33350
yes
no
Details
-
-
303
31730
12130
yes
no
Details
-
-
115
30000
10090
yes
no
Details
-
-
178
92800
yes
yes
0.48 mg/kg
Details
-
-
118
81882
23830
yes
no
Details
-
-
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
-
-
770
51700
yes
no
0.05 mg/kg
Details
-
-
315
46640
yes
no
3 mg/kg
Details
-
-
477
46720
yes
yes
4.8 mg/kg
Details
-
-
765
49485
yes
yes
1 mg/kg
Details
-
-
756
40020
yes
yes
Details
-
-
758
38940
yes
yes
Details
-
-
472
66560
yes
yes
Details
-
-
137
66580
yes
yes
Details

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