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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203-865-4
111-40-0
261
15790
no
no
5 mg/kg
Details
203-542-8
108-01-0
230
16150
no
no
18 mg/kg
Details
204-794-1
126-58-9
311
51200
16480
yes
no
Details
203-005-8
102-09-0
201
16540
no
no
0.05 mg/kg
Details
204-853-1
127-63-9
313
51570
16650
yes
no
3 mg/kg
Details
202-966-0
101-68-8
198
16630
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
203-821-4
110-98-5
257
16660
13550
51760
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
233-466-0
10191-41-0
110
93520
yes
no
Details
240-440-2
16389-88-1
623
52640
yes
no
Details
203-439-8
106-89-8
219
14570
16750
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
204-009-2
112-84-5
271
52720
yes
no
Details
204-011-3
112-86-7
273
52730
yes
no
Details
203-468-6
107-15-3
226
16960
15272
no
no
12 mg/kg
Details
203-473-3
107-21-1
227
53650
16990
yes
no
Details
205-793-9
151-56-4
334
17005
no
no
0.01 mg/kg
Details
203-743-0
110-17-8
249
55120
17290
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
203-817-2
110-94-1
256
18010
55680
yes
no
Details
203-593-6
108-55-4
238
18070
no
no
Details
242-471-7
18641-57-1
626
57800
yes
no
Details
215-637-1
1335-58-6
40
56360
yes
no
Details
234-397-9
11140-02-6
47
56520
yes
no
Details
234-400-3
11140-06-0
50
56550
yes
no
Details
234-325-6
11099-07-3
53
56585
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
204-127-4
116-15-4
282
18430
no
no
0.01 mg/kg
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
811-989-0
12072-90-1
600
60030
yes
no
Details
602-916-1
12304-65-3
604
60080
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
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
204-506-4
121-91-5
291
19150
no
no
Details
215-951-9
1459-93-4
420
19210
no
no
0.05 mg/kg
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
205-316-4
138-22-7
322
63040
yes
no
Details
205-582-1
143-07-7
330
63280
19470
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
233-822-5
10377-51-2
588
64320
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
205-503-0
141-82-2
328
65040
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
203-441-9
106-91-2
220
20590
no
no
0.02 mg/kg
Details
234-207-4
10595-80-9
590
21370
no
no
0.01 mg/kg
Details
202-943-5
101-43-9
197
20260
no
no
0.05 mg/kg
Details
204-817-5
126-98-7
312
21490
no
no
0.01 mg/kg
Details
601-648-2
12001-26-2
597
67120
yes
no
Details
215-263-9
1317-33-5
404
67200
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
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
795
40155
yes
no
0.05 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
203-755-6
110-30-5
250
53520
yes
no
Details
203-041-4
102-60-3
204
92640
25180
yes
no
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
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
204-019-7
112-96-9
274
22570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
233-226-5
10094-45-8
587
68400
yes
yes
5 mg/kg
Details
204-007-1
112-80-1
270
22763
69040
yes
no
Details
205-597-3
143-28-2
332
69760
yes
no
Details
240-367-6
16260-09-6
622
69840
yes
yes
5 mg/kg
Details
205-634-3
144-62-7
333
22775
69920
yes
no
6 mg/kg
Details
680-864-9
12198-93-5
602
70240
yes
no
Details
203-398-6
106-44-5
216
14770
no
no
Details
203-829-8
111-06-8
258
70480
yes
no
Details
204-104-9
115-77-5
279
22840
71600
yes
no
Details
429-160-3
178671-58-4
778
71670
yes
yes
0.05 mg/kg
Details
203-692-4
109-66-0
244
71720
yes
no
Details
623-712-9
14797-73-0
822
71938
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
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.
Details
216-600-2
1623-05-8
423
22937
no
no
0.05 mg/kg
Details
682-238-0
1190931-27-1
1045
yes
no
Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.
Details
203-632-7
108-95-2
241
22960
no
no
3 mg/kg
Details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
Details
204-118-5
115-96-8
280
73720
yes
no
0.01 mg/kg
Details
IRGAFOS 38
416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
204-552-5
122-52-1
293
23175
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
843-672-8
1227937-46-3
1076
yes
no
0.05 mg/kg
Only to be used (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.
Details
204-211-0
117-81-7
283
74640
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
Details
204-211-0
117-81-7
283
74640
yes
no
0.6 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
Details
204-211-0
117-81-7
283
74640
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
Details
205-016-3
131-17-9
316
23230
no
no
0.01 mg/kg
Details
923-642-1
106392-12-5
551
79920
yes
no
Details
-
147398-31-0
1059
no
no
The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000Da shall not exceed 5.0 mg/kg food.
Details
630-556-5
124578-12-7
812
80350
yes
no
Only to be used in plastics up to 0,1 % w/w.
Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.
Details
-
1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
Details
606-265-4
192268-64-7
780
81220
yes
no
5 mg/kg
Details
-
167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
Details
215-181-3
1310-58-3
399
81600
yes
no
Details
204-623-0
123-38-6
296
23860
no
no
Details
203-293-5
105-38-4
211
23920
no
no
Details
204-638-2
123-62-6
297
23950
no
no
Details
204-062-1
115-07-1
275
23980
no
no
Details
-
13445-56-2
609
83455
yes
no
Details
602-803-7
12269-78-2
603
83460
yes
no
Details
238-878-4
14808-60-7
616
83470
yes
no
Details
432-130-2
119345-01-6
760
83595
yes
no
18 mg/kg
Composition: 4,4'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)),4,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)),3,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)),4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)),tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)),4,4'-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))(*)Quantity of substance used/quantity of formulationOther specifications: Phosphor content of min. 5,4 % to max. 5,9 %,Acid value of max. 10 mg KOH per gram,Melt range of 85- 110 °C.
Details
202-987-5
101-90-6
199
24073
no
no
0.01 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
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
Details
204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
Details
203-845-5
111-20-6
260
24280
no
no
Details
203-672-5
109-43-3
242
85360
yes
no
Details
215-683-2
1343-98-2
417
85680
yes
no
Details
215-185-5
1310-73-2
400
86720
yes
no
Details
215-211-5
1313-82-2
401
24475
no
no
Details
215-540-4
1330-43-4
407
87040
yes
no
Details
203-768-7
110-44-1
252
87200
yes
no
Details
215-663-3
1338-39-2
414
87600
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
204-693-2
124-26-5
306
88960
yes
no
Details
204-666-5
123-95-5
301
89120
yes
no
Details
202-851-5
100-42-5
193
24610
no
no
Details
203-740-4
110-15-6
247
90960
24820
yes
no
Details
203-570-0
108-30-5
233
24850
no
no
Details
204-771-6
126-13-6
308
91200
yes
no
Details
204-772-1
126-14-7
309
91360
yes
no
Details
238-877-9
14807-96-6
615
92080
yes
no
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
202-830-0
100-21-0
785
24910
no
no
Details
202-829-5
100-20-9
191
24940
no
no
Details
204-411-8
120-61-6
288
24970
no
no
Details
203-989-9
112-60-7
269
92350
25090
yes
no
Details
204-126-9
116-14-3
281
25120
no
no
0.05 mg/kg
Details
203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
Details
SYNESAL M
404-440-8
120218-34-0
761
92930
yes
no
6 mg/kg
Details
204-614-1
123-28-4
294
93120
yes
yes
Details
240-613-2
16545-54-3
894
93360
yes
no
Details
236-675-5
13463-67-7
610
93440
yes
no
Details
234-354-4
11116-16-8
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
203-048-2
102-70-5
205
25385
no
no
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.
Only to be used in hydrogels intended for non-direct food contact use.
Details
203-049-8
102-71-6
793
94000
yes
no
Details
203-953-2
112-27-6
266
25510
94320
yes
no
Details
204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
Details
203-812-5
110-88-3
255
25900
no
no
5 mg/kg
Details
MICROLITE (R) POWDER; MICROLITE (R) VERMICULITE DISPERSIONS; MICROLITE POWDER; MICROLITE SPECIALITY VERMICULITE; MICROLITE VERMICULITE DISPERSIONS; MICROLITE-VERMICULITDISPERSIONEN
406-060-8
110638-71-6
757
95725
yes
no
Details
237-772-5
13983-17-0
613
95905
yes
no
Details
234-394-2
11138-66-2
596
95935
yes
no
Details
215-222-5
1314-13-2
402
96240
yes
no
Details
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.
Details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
Details
215-251-3
1314-98-3
403
96320
yes
no
Details
604-838-3
152261-33-1
803
33535
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Not to be used in contact with alcoholic foods.
Details
233-007-4
10016-20-3
580
46070
yes
no
Details
641-029-4
156065-00-8
874
16265
no
no
0.05 mg/kg
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
641-029-4
156065-00-8
874
16265
no
no
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
204-872-5
127-91-3
314
23500
no
no
Details
607-698-1
25322-99-0
865
40619
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.
Details
608-050-0
27136-15-8
869
66763
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.
Details
THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE
405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
-
23985-75-3
1066
no
no
0.05 mg/kg
Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III.
The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).
Details
245-217-3
22788-19-8
630
82240
yes
no
Details
248-315-4
27194-74-7
659
82800
yes
no
Details
249-369-1
29013-28-3
665
83120
yes
no
Details
248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
Details
-
227099-60-7
781
95265
yes
no
0.05 mg/kg
Details
219-371-7
2425-79-8
442
13780
no
no
0.01 mg/kg
Residual content = 1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
Details
412-440-4
2725-22-6
452
38885
yes
no
5 mg/kg
Details
247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
219-470-5
2440-22-4
444
61440
yes
no
Details
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
220-239-6
2682-20-4
451
66755
yes
no
0.5 mg/kg
Only to be used in aqueous polymer dispersions and emulsions.
Details
-
203255-81-6
792
92475
yes
yes
5 mg/kg
SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products.
Details
245-818-0
23676-09-7
632
52880
yes
no
3.6 mg/kg
Details
219-784-2
2530-83-8
1068
no
no
Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).
Details
219-785-8
2530-85-0
788
21498
no
no
0.05 mg/kg
Only to be used as a surface treatment agent of inorganic fillers.
Details
681-637-7
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
Details
681-637-7
25134-51-4
636
31500
yes
no
Details
219-673-9
2495-35-4
446
10750
no
no
Details
218-463-4
2156-97-0
437
11245
no
no
0.05 mg/kg
Details
219-696-4
2499-59-4
448
11890
no
no
Details
221-072-1
2998-08-5
456
10810
no
no
Details
218-001-1
2035-75-8
432
12280
no
no
Details

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