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.
Filter the list

 
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-
752
39890
yes
no
Details
-
-
17
34281
yes
no
Details
232-680-1
9005-32-7
566
33350
yes
no
Details
-
-
13
33120
yes
no
Details
-
-
3
12375
no
no
Details
-
-
2
12340
no
no
Details
-
266309-43-7
1
12310
no
no
Details
218-001-1
2035-75-8
432
12280
no
no
Details
203-090-1
103-23-1
207
31920
yes
yes
Details
204-673-3
124-04-9
303
31730
12130
yes
no
Details
216-768-7
1663-39-4
425
10840
no
no
Details
221-072-1
2998-08-5
456
10810
no
no
Details
213-120-5
925-60-0
380
11980
no
no
Details
219-696-4
2499-59-4
448
11890
no
no
Details
205-480-7
141-32-2
325
10780
no
no
Details
212-454-9
818-61-1
371
11830
11510
no
no
Details
-
174254-23-0
777
31542
yes
no
0,5 % in final product.
Details
202-500-6
96-33-3
176
11710
no
no
Details
211-710-7
689-12-3
365
11680
no
no
Details
203-417-8
106-63-8
218
11590
no
no
Details
205-438-8
140-88-5
323
11470
no
no
Details
219-673-9
2495-35-4
446
10750
no
no
Details
681-637-7
25134-51-4
636
31500
yes
no
Details
201-177-9
79-10-7
147
10690
no
no
Details
500-148-0
61788-89-4
705
10599/91
10599/90A
no
no
Details
500-231-1
68783-41-5
733
10599/93
10599/92A
no
no
Details
-
-
12
31328
yes
no
Details
-
-
880
31348
yes
no
Details
-
-
878
31335
yes
no
Details
-
-
879
31336
yes
no
Details
-
-
10
30612
yes
no
Details
-
-
801
30607
yes
no
Details
-
-
9
30610
yes
no
Details
-
-
11
30960
yes
no
Details
200-816-9
74-86-2
126
10210
no
no
Details
-
-
8
30401
yes
no
Details
-
-
7
30370
yes
no
Details
200-662-2
67-64-1
119
30295
yes
no
Details
203-564-8
108-24-7
232
30280
10150
yes
no
Details
205-500-4
141-78-6
327
30140
yes
no
Details
204-658-1
123-86-4
300
30045
yes
no
Details
200-580-7
64-19-7
115
30000
10090
yes
no
Details
200-836-8
75-07-0
128
10060
no
no
Details
208-178-3
514-10-3
346
10030
no
no
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
222-067-7
3333-62-8
465
68040
yes
no
Details
202-307-7
94-13-3
173
60240
yes
no
Details
202-785-7
99-76-3
189
60200
yes
no
Details
224-069-3
4191-73-5
478
60180
yes
no
Details
204-399-4
120-47-8
287
60160
yes
no
Details
210-288-1
611-99-4
359
15970
48720
yes
no
Details
-
958445-44-8
896
71958
yes
no
Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.
Details
616-996-0
80181-31-3
744
18888
no
no
The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.
Details
236-946-8
13560-49-1
611
35120
yes
no
Details
221-532-1
3135-18-0
459
46870
yes
no
Details
267-342-2
67845-93-6
721
46800
yes
no
Details
224-166-0
4221-80-1
480
46790
yes
no
Details
202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
-
37486-69-4
903
yes
no
Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.
Details
200-661-7
67-63-0
118
81882
23830
yes
no
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
203-452-9
107-01-7
224
13900
no
no
Details
219-470-5
2440-22-4
444
61440
yes
no
Details
223-383-8
3864-99-1
469
60480
yes
yes
Details
223-445-4
3896-11-5
470
60400
yes
yes
Details
202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
205-029-4
131-56-6
318
48640
yes
no
Details
CG 25-1320; IRGANOX 1520; TK 12229/1
402-860-6
110553-27-0
756
40020
yes
yes
Details
438-600-3
110675-26-8
758
38940
yes
yes
Details
813-638-7
80512-44-3
1061
no
no
Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.
Details
-
1547-26-8
1063
no
no
Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
Details
216-823-5
1675-54-3
426
13610
13510
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
Details
274-572-7
70331-94-1
739
70000
yes
no
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
205-026-8
131-53-3
317
48880
yes
yes
Details
203-366-1
106-14-9
214
61840
yes
no
Details
200-746-9
71-23-8
122
23800
no
no
Details
200-752-1
71-41-0
124
22870
no
no
Details
203-917-6
111-87-5
265
22600
no
no
Details
205-583-7
143-08-8
331
22480
no
no
Details
223-861-6
4098-71-9
475
19110
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
253-149-0
36653-82-4
681
18310
no
no
Details
203-956-9
112-30-1
267
15100
no
no
Details
203-449-2
106-98-9
222
13870
no
no
Details
200-751-6
71-36-3
123
13840
no
no
Details
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
203-782-3
110-60-1
253
15250
no
no
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
203-786-5
110-63-4
254
40580
13720
yes
no
Details
203-268-9
105-08-8
210
13390
14880
no
no
Details
203-529-7
107-88-0
228
13690
no
no
Details
222-852-4
3634-83-1
988
no
no
SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine.
To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.
Details
216-032-5
1477-55-0
421
13000
no
no
Details
216-971-0
1709-70-2
428
95200
yes
no
Details
215-354-3
1323-39-3
406
83300
yes
no
Details
249-369-1
29013-28-3
665
83120
yes
no
Details
215-549-3
1330-80-9
408
82960
yes
no
Details
248-315-4
27194-74-7
659
82800
yes
no
Details
228-229-3
6182-11-2
491
82720
yes
no
Details
251-581-4
33587-20-1
677
82560
yes
no
Details
203-315-3
105-62-4
213
82400
yes
no
Details
245-217-3
22788-19-8
630
82240
yes
no
Details
618-414-0
9005-37-2
567
82080
yes
no
Details
200-338-0
57-55-6
109
23740
81840
yes
no
Details
431-890-2
166412-78-8
775
45705
yes
no
Details
204-886-1
128-44-9
902
yes
no
The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (OJ L 83, 22.3.2012, p. 1).
Details
271-091-4
68515-49-1
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
271-091-4
68515-49-1
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
271-090-9
68515-48-0
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
271-090-9
68515-48-0
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
200-866-1
75-37-6
131
48460
yes
no
Details
480-340-8
156157-97-0
1080
yes
no
Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.
Details
480-340-8
156157-97-0
1080
yes
no
Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.
Details
-
-
979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
243-053-7
19430-93-4
973
22931
no
no
Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.
Details
-
37953-21-2
857
66765
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
Details
-
-
1016
yes
no
Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA.
The final material shall be used at room temperature or below.
Details
618-459-6
9010-88-2
868
53245
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
-
40471-03-2
867
40815
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.
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
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
-
-
866
40620
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.
Details
-
-
855
40560
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
Details
-
-
998
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
-
-
859
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
-
-
1043
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
617-241-8
81541-12-0
752
39890
yes
no
Details
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
Details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
-
-
74
77440
yes
yes
42 mg/kg
Details
-
-
324
83700
yes
yes
42 mg/kg
Details
246-563-8
25013-16-5
635
40720
yes
no
30 mg/kg
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
204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
Details
-
-
69
74400
yes
yes
30 mg/kg
Details
-
-
14
33801
yes
no
30 mg/kg
Details
202-510-0
96-49-1
177
16955
no
no
30 mg/kg
SML expressed as ethyleneglycol.
Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.
Details
248-289-4
27176-87-0
658
52000
yes
no
30 mg/kg
Details
-
-
658
52000
yes
no
30 mg/kg
Details
-
-
209
17050
no
no
30 mg/kg
Details
-
-
15
34130
yes
yes
30 mg/kg
Details
203-234-3
104-76-7
209
17050
no
no
30 mg/kg
Details
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
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
203-542-8
108-01-0
230
16150
no
no
18 mg/kg
Details
264-122-8
63397-60-4
710
38700
yes
yes
18 mg/kg
Details
203-090-1
103-23-1
207
31920
yes
yes
18 mg/kg
Details
-
-
91
92320
yes
yes
15 mg/kg
Details
251-156-3
32687-78-8
675
38800
yes
yes
15 mg/kg
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
203-468-6
107-15-3
226
16960
15272
no
no
12 mg/kg
Details
-
-
25
45440
yes
no
12 mg/kg
Details
209-530-9
584-09-8
353
42480
yes
no
12 mg/kg
Details
203-545-4
108-05-4
231
10120
no
no
12 mg/kg
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
203-400-5
106-46-7
217
15565
no
no
12 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
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
Details
-
-
88
86880
yes
no
9 mg/kg
Details
SYNESAL M
404-440-8
120218-34-0
761
92930
yes
no
6 mg/kg
Details
-
-
71
76730
yes
no
6 mg/kg
Details
201-622-7
85-68-7
159
74560
yes
no
6 mg/kg
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.
Details
205-634-3
144-62-7
333
22775
69920
yes
no
6 mg/kg
Details
218-216-0
2082-79-3
433
68320
yes
yes
6 mg/kg
Details
200-311-3
57-09-0
104
58960
yes
no
6 mg/kg
Details
251-073-2
32509-66-3
673
53670
yes
yes
6 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
-
-
333
22775
69920
yes
no
6 mg/kg
Details
-
-
16
34230
yes
no
6 mg/kg
Details
262-634-6
61167-58-6
700
31520
yes
yes
6 mg/kg
Details
202-200-5
92-88-6
170
16000
no
no
6 mg/kg
Details
235-841-4
13003-12-8
608
40800
yes
yes
6 mg/kg
Details
265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
Details
403-020-1
118337-09-0
759
54300
yes
yes
6 mg/kg
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
Details
254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
Details
204-427-5
120-80-9
289
24051
15880
no
no
6 mg/kg
Details
201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
Details

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