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 25 April 2024. Database contains 1080 unique substances/entries.
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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
228-253-4
6200-40-4
493
39200
yes
no
1.8 mg/kg
Details
413-110-2
135861-56-2
766
38879
yes
no
Details
NC-4
406-176-9
79072-96-1
743
38950
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
-
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
614-830-1
68951-50-8
735
40120
yes
no
0.6 mg/kg
Details
233-139-2
10043-35-3
584
40320
13620
yes
no
Details
233-136-6
10043-11-5
583
40400
yes
no
Details
203-448-7
106-97-8
221
40570
yes
no
Details
227-265-7
5743-36-2
489
41040
yes
no
Details
233-140-8
10043-52-4
585
41120
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
200-945-0
76-22-2
136
41680
yes
no
Details
The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.
232-347-0
8006-44-8
530
41760
yes
no
Details
203-313-2
105-60-2
212
41840
14200
yes
no
Details
204-677-5
124-07-2
304
14320
41960
yes
no
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
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
204-696-9
124-38-9
307
42160
yes
no
Details
209-530-9
584-09-8
353
42480
yes
no
12 mg/kg
Details
-
-
21
42500
yes
no
Details
618-326-2
9000-11-7
542
42640
yes
no
Details
The wax derived from Copernicia cerifera, Palmae.
232-399-4
8015-86-9
533
42720
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
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
264-705-7
64147-40-6
712
42960
yes
no
Details
-
-
22
43200
yes
no
Details
232-674-9
9004-34-6
553
43280
14500
yes
no
Details
618-381-2
9004-36-8
554
43300
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
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
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
-
-
23
43515
yes
no
0.9 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
-
-
816
45704
yes
no
5 mg/kg
Details
-
10436-08-5
589
52645
yes
no
Details
-
-
817
38507
yes
no
5 mg/kg
Not to be used with polyethylene in contact with acidic foods.
Purity ≥ 96 %.
Details
201-069-1
77-92-9
139
44160
14680
yes
no
Details
201-070-7
77-93-0
140
44640
yes
no
Details
234-334-5
11104-61-3
593
44960
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
232-131-6
7787-70-4
523
45195
yes
no
Details
235-285-2
12158-74-6
972
45197
yes
no
Details
215-625-6
1335-23-5
412
45200
yes
no
Details
-
-
24
45280
yes
no
Details
-
-
25
45440
yes
no
12 mg/kg
Details
238-455-4
14464-46-1
614
45560
yes
no
Details
223-077-4
3724-65-0
467
45600
14800
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
203-629-0
108-91-8
240
45760
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
611-185-8
54686-97-4
752
39890
yes
no
Details
281-837-0
84030-61-5
747
47600
yes
yes
Details
-
69226-46-6
30
50560
yes
no
Details
233-117-2
10039-33-5
582
50240
yes
no
Details
239-622-4
15571-58-1
619
50320
yes
no
Details
268-500-3
68109-88-6
29
50360
yes
no
Details
251-576-7
33568-99-9
676
50400
yes
no
Details
247-666-0
26401-97-8
646
50480
yes
no
Details
-
-
28
50160
yes
no
Details
222-883-3
3648-18-8
466
50640
yes
no
Details
239-625-0
15571-60-5
620
50720
yes
no
Details
-
-
31
50800
yes
no
Details
-
-
32
50880
yes
no
Details
260-414-4
56875-68-4
736
50960
yes
no
Details
239-581-2
15535-79-2
618
51040
yes
no
Details
-
-
33
51120
yes
no
Details
248-468-7
27458-90-8
660
47540
yes
yes
0.05 mg/kg
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
272-489-0
68855-54-9
734
46380
yes
no
Details
251-136-4
32647-67-9
674
46480
yes
no
Details
-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
Details
203-872-2
111-46-6
263
47680
13326
15760
yes
no
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
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
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
200-664-3
67-68-5
120
49540
yes
no
Details
260-829-0
57583-35-4
698
49595
yes
no
Details
247-862-6
26636-01-1
650
49600
yes
no
Details
219-702-5
2500-88-1
449
49840
yes
yes
0.05 mg/kg
Details
204-794-1
126-58-9
311
51200
16480
yes
no
Details
204-853-1
127-63-9
313
51570
16650
yes
no
3 mg/kg
Details
246-770-3
25265-71-8
257
16660
13550
51760
yes
no
Details
203-821-4
110-98-5
257
16660
13550
51760
yes
no
Details
233-466-0
10191-41-0
110
93520
yes
no
Details
-
287916-86-3
871
yes
no
Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.
Details
248-289-4
27176-87-0
658
52000
yes
no
30 mg/kg
Details
240-440-2
16389-88-1
623
52640
yes
no
Details
204-009-2
112-84-5
271
52720
yes
no
Details
204-011-3
112-86-7
273
52730
yes
no
Details
200-578-6
64-17-5
113
52800
16780
yes
no
Details
-
37205-99-5
682
53270
yes
no
Details
618-384-9
9004-57-3
555
53280
yes
no
Details
251-073-2
32509-66-3
673
53670
yes
yes
6 mg/kg
Details
210-826-5
624-03-3
1048
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
-
5136-44-7
486
54005
yes
no
Details
429-840-1
24937-78-8
969
yes
no
Only to be used as a polymeric additive up to 2 % w/w in polyolefins.
The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
Details
200-449-4
60-00-4
111
53600
yes
no
Details
203-473-3
107-21-1
227
53650
16990
yes
no
Details
618-385-4
9004-58-4
556
54260
yes
no
Details
-
-
34
54270
yes
no
Details
-
-
35
54280
yes
no
Details
-
-
36
54450
yes
no
Details
-
-
37
54480
yes
no
Details
-
-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
200-001-8
50-00-0
98
17260
54880
yes
no
Details
607-708-4
25359-91-5
640
54930
yes
no
0.05 mg/kg
Details
200-579-1
64-18-6
114
55040
yes
no
Details
203-743-0
110-17-8
249
55120
17290
yes
no
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
203-817-2
110-94-1
256
18010
55680
yes
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
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
200-311-3
57-09-0
104
58960
yes
no
6 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
695-178-5
9044-17-1
577
62280
yes
no
Details
201-142-8
78-78-4
143
62450
yes
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
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
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
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
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

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