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 19 April 2024. Database contains 1080 unique substances/entries.
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211-750-5
693-36-7
368
93280
yes
yes
Details
204-614-1
123-28-4
294
93120
yes
yes
Details
255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
Details
254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
Details
-
-
91
92320
yes
yes
15 mg/kg
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
Details
270-476-4
68442-12-6
726
83599
yes
yes
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
-
-
74
77440
yes
yes
42 mg/kg
Details
-
-
73
76866
yes
yes
Details
-
-
73
76866
yes
yes
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
Details
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
Details
-
-
69
74400
yes
yes
30 mg/kg
Details
700-485-5
939402-02-5
974
74050
yes
yes
10 mg/kg
SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.
Details
700-485-5
939402-02-5
974
74050
yes
yes
1 mg/kg
The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.
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
-
-
68
73160
yes
yes
0.05 mg/kg
Details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
Details
429-160-3
178671-58-4
778
71670
yes
yes
0.05 mg/kg
Details
271-867-2
68610-51-5
732
45450
yes
yes
5 mg/kg
Details
240-367-6
16260-09-6
622
69840
yes
yes
5 mg/kg
Details
233-226-5
10094-45-8
587
68400
yes
yes
5 mg/kg
Details
218-216-0
2082-79-3
433
68320
yes
yes
6 mg/kg
Details
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
203-004-2
102-08-9
200
51680
yes
yes
3 mg/kg
Details
251-156-3
32687-78-8
675
38800
yes
yes
15 mg/kg
Details
251-073-2
32509-66-3
673
53670
yes
yes
6 mg/kg
Details
219-702-5
2500-88-1
449
49840
yes
yes
0.05 mg/kg
Details
248-468-7
27458-90-8
660
47540
yes
yes
0.05 mg/kg
Details
281-837-0
84030-61-5
747
47600
yes
yes
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
-
-
324
83700
yes
yes
42 mg/kg
Details
-
-
178
92800
yes
yes
0.48 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
-
-
285
66480
yes
yes
Details
-
-
15
34130
yes
yes
30 mg/kg
Details
203-090-1
103-23-1
207
31920
yes
yes
18 mg/kg
Details
203-090-1
103-23-1
207
31920
yes
yes
Details
262-634-6
61167-58-6
700
31520
yes
yes
6 mg/kg
Details
SUMILIZER GS
413-850-6
123968-25-2
762
31530
yes
yes
5 mg/kg
Details
682-678-3
182121-12-6
779
39815
yes
yes
0.05 mg/kg
Details
202-525-2
96-69-5
178
92800
yes
yes
0.48 mg/kg
Details
235-841-4
13003-12-8
608
40800
yes
yes
6 mg/kg
Details
216-245-3
1533-45-5
422
38515
yes
yes
0.05 mg/kg
Details
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
858
38565
yes
yes
0.05 mg/kg
SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer.
Details
430-800-9
129228-21-3
763
39925
yes
yes
0.05 mg/kg
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
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
217-421-2
1843-05-6
431
61600
yes
yes
Details
-
3293-97-8
464
61280
yes
yes
Details
205-031-5
131-57-7
319
61360
yes
yes
Details
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
274-570-6
70321-86-7
738
60320
yes
yes
1.5 mg/kg
Details
257-624-3
52047-59-3
692
52320
yes
yes
0.06 mg/kg
Details
223-383-8
3864-99-1
469
60480
yes
yes
Details
223-445-4
3896-11-5
470
60400
yes
yes
Details
223-945-2
4130-42-1
477
46720
yes
yes
4.8 mg/kg
Details
230-426-4
7128-64-5
500
38560
yes
yes
0.6 mg/kg
Details
CG 27-145
411-220-5
134701-20-5
765
49485
yes
yes
1 mg/kg
Details
CG 25-1320; IRGANOX 1520; TK 12229/1
402-860-6
110553-27-0
756
40020
yes
yes
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
438-600-3
110675-26-8
758
38940
yes
yes
Details
423-560-1
161717-32-4
774
95270
yes
yes
2 mg/kg
SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP.
Details
-
78301-43-6
742
92700
yes
yes
5 mg/kg
Details
223-773-8
4066-02-8
472
66560
yes
yes
Details
201-044-5
77-62-3
137
66580
yes
yes
Details
204-327-1
119-47-1
285
66480
yes
yes
Details
201-814-0
88-24-4
163
66400
yes
yes
Details
286-344-4
85209-91-2
749
66360
yes
yes
5 mg/kg
Details
403-020-1
118337-09-0
759
54300
yes
yes
6 mg/kg
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
205-026-8
131-53-3
317
48880
yes
yes
Details
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
796
72141
yes
yes
0.05 mg/kg
SML including the sum of its hydrolysis products.
Details
279-459-6
80410-33-9
745
68145
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
Details
248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
Details
252-816-3
35958-30-6
679
39060
yes
yes
5 mg/kg
Details
217-420-7
1843-03-4
430
95600
yes
yes
5 mg/kg
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
204-872-5
127-91-3
314
23500
no
no
Details
231-493-2
7585-39-9
503
46080
yes
no
Details
201-291-9
80-56-8
155
23470
no
no
Details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
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
233-007-4
10016-20-3
580
46070
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
215-251-3
1314-98-3
403
96320
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
243-814-3
20427-58-1
628
96190
yes
no
Details
234-394-2
11138-66-2
596
95935
yes
no
Details
237-772-5
13983-17-0
613
95905
yes
no
Details
-
-
95
95883
yes
no
Average molecular weight not less than 480 Da.
Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
Details
-
-
94
95859
yes
no
Average molecular weight not less than 500 Da.
Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
Details
-
-
93
95858
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.
Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).
Details
231-791-2
7732-18-5
515
95855
26360
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
Details
220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
Details
201-081-7
78-08-0
142
26305
no
no
0.05 mg/kg
Only to be used as a surface treatment agent.
Details
200-867-7
75-38-7
132
26140
no
no
5 mg/kg
Details
200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
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
200-315-5
57-13-6
107
25960
no
no
Details
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
Details
222-020-0
3319-31-1
1078
yes
no
1 mg/kg
Only to be used as plasticiser to manufacture soft poly(vinyl chloride).
Not to be used in contact with foods intended for infants.
Details
246-466-0
24800-44-0
634
25910
no
no
Details
203-812-5
110-88-3
255
25900
no
no
5 mg/kg
Details
-
-
924
94987
yes
no
0.05 mg/kg
Only for use in PET in contact with all types of foods other than fatty, high- alcoholic and dairy products.
Details
-
-
815
94985
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
-
-
815
94985
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
927-697-2
28931-67-1
664
95000
yes
no
Details
219-547-3
2459-10-1
971
25885
no
no
Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.
Details
209-008-0
552-30-7
349
25550
no
no
Details
208-432-3
528-44-9
347
25540
13050
no
no
Details
204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
Details
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
Details
203-953-2
112-27-6
266
25510
94320
yes
no
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
203-049-8
102-71-6
793
94000
yes
no
Details
-
-
92
93970
yes
no
0.05 mg/kg
Details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
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
-
-
5
25360
no
no
0.01 mg/kg
1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
-
-
6
25380
no
no
0.05 mg/kg
Details
201-067-0
77-90-7
138
93760
yes
no
Details
232-552-5
9000-65-1
545
93680
yes
no
Details
231-710-0
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
247-117-5
25583-20-4
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
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
-
-
805
93450
yes
no
The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w.
Details
-
-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
Details
-
-
873
93460
yes
no
Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
Details
236-675-5
13463-67-7
610
93440
yes
no
Details
240-613-2
16545-54-3
894
93360
yes
no
Details
SYNESAL M
404-440-8
120218-34-0
761
92930
yes
no
6 mg/kg
Details
203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
Details
204-126-9
116-14-3
281
25120
no
no
0.05 mg/kg
Details
203-989-9
112-60-7
269
92350
25090
yes
no
Details
246-563-8
25013-16-5
635
40720
yes
no
30 mg/kg
Details
204-411-8
120-61-6
288
24970
no
no
Details
260-815-4
57569-40-1
696
92205
yes
no
Details
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
Details
229-176-9
6422-86-2
798
92200
yes
no
Details
202-829-5
100-20-9
191
24940
no
no
Details
202-830-0
100-21-0
785
24910
no
no
Details
-
-
90
92195
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
238-877-9
14807-96-6
615
92080
yes
no
Details
270-337-8
68425-17-2
724
24903
no
no
In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].
Details
231-639-5
7664-93-9
511
91920
yes
no
Details
231-722-6
7704-34-9
514
91840
yes
no
Details
-
-
814
91815
yes
no
2 mg/kg
Details
-
-
813
91530
yes
no
5 mg/kg
Details
204-772-1
126-14-7
309
91360
yes
no
Details
204-771-6
126-13-6
308
91200
yes
no
Details
200-334-9
57-50-1
108
24880
no
no
Details
203-570-0
108-30-5
233
24850
no
no
Details
203-740-4
110-15-6
247
90960
24820
yes
no
Details
248-104-7
26914-43-2
656
24760
no
no
0.05 mg/kg
Details
843-371-1
25101-28-4
856
40563
yes
no
Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
Details
202-851-5
100-42-5
193
24610
no
no
Details
261-257-4
58446-52-9
699
90720
yes
no
Details
-
-
821
90810
yes
no
Details
-
-
89
89440
yes
no
Details
204-666-5
123-95-5
301
89120
yes
no
Details
200-313-4
57-11-4
106
24550
89040
yes
no
Details
204-693-2
124-26-5
306
88960
yes
no
Details
686-629-7
68412-29-3
723
88880
yes
no
Details
High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.
232-679-6
9005-25-8
564
24540
88800
yes
no
Details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
232-391-0
8013-07-8
532
88640
yes
no
Details
232-391-0
8013-07-8
532
88640
yes
no
30 mg/kg
In the case of PVC gaskets used to seal glass jars containing 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, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).
232-274-4
8001-22-7
524
24520
no
no
Details
248-027-9
26836-47-5
654
88600
yes
no
Details
200-061-5
50-70-4
100
88320
24490
yes
no
Details
247-891-4
26658-19-5
651
88240
yes
no
Details
258-994-9
54140-20-4
693
88160
yes
no
Details
247-569-3
26266-58-0
644
88080
yes
no
Details
262-958-8
61752-68-9
702
87920
yes
no
Details
215-664-9
1338-41-6
415
87840
yes
no
Details
247-568-8
26266-57-9
643
87760
yes
no
Details
215-665-4
1338-43-8
416
87680
yes
no
Details
215-663-3
1338-39-2
414
87600
yes
no
Details

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