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 29 March 2024. Database contains 1080 unique substances/entries.
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206-103-9
301-02-0
335
68960
yes
no
Details
206-765-9
373-49-9
338
71020
yes
no
Details
682-234-9
329238-24-6
854
71943
yes
no
Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles.
Details
223-320-4
3825-26-1
468
71960
yes
no
Only to be used in repeated use articles, sintered at high temperatures.
Details
250-709-6
31570-04-4
671
74240
yes
no
Details
608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
Details
608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
Details
442-650-1
37296-97-2
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
254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
Details
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
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
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
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
224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
Details
254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
Details
223-805-0
4080-31-3
474
43600
yes
no
0.3 mg/kg
Details
223-861-6
4098-71-9
475
19110
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
223-773-8
4066-02-8
472
66560
yes
yes
Details
225-306-3
4767-03-7
484
13395
no
no
0.05 mg/kg
Details
223-945-2
4130-42-1
477
46720
yes
yes
4.8 mg/kg
Details
256-318-7
47465-97-4
691
13600
no
no
1.8 mg/kg
Details
224-166-0
4221-80-1
480
46790
yes
no
Details
224-709-1
4457-71-0
883
22074
no
no
0.05 mg/kg
Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg.
Details
224-069-3
4191-73-5
478
60180
yes
no
Details
223-792-1
4074-90-2
473
12265
no
no
0.01 mg/kg
5 mg/kg in final product.
Only to be used as co-monomer.
Details
-
4196-95-6
479
12970
no
no
Details
207-866-0
498-66-8
341
22550
13180
no
no
0.05 mg/kg
Details
207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
Details
626-593-1
4128-73-8
476
16570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
225-094-2
4655-34-9
482
21100
no
no
Details
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
Details
225-218-5
4724-48-5
483
68860
yes
no
0.05 mg/kg
Details
206-991-8
409-21-2
339
86160
yes
no
Details
255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
Details
200-338-0
57-55-6
109
23740
81840
yes
no
Details
207-997-3
504-63-2
343
23770
no
no
0.05 mg/kg
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
208-015-6
505-65-7
344
21821
13810
no
no
0.05 mg/kg
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
200-254-4
56-06-4
864
46330
yes
no
5 mg/kg
Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.
Details
209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
Details
257-624-3
52047-59-3
692
52320
yes
yes
0.06 mg/kg
Details
226-029-0
5232-99-5
487
45640
yes
no
0.05 mg/kg
Details
209-929-8
598-32-3
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
209-249-1
563-45-1
351
21730
no
no
0.01 mg/kg
Only to be used in polypropylene.
Details
209-968-0
599-64-4
358
14841
no
no
0.05 mg/kg
Details
208-178-3
514-10-3
346
10030
no
no
Details
200-412-2
59-02-9
110
93520
yes
no
Details
200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
208-031-3
506-30-9
345
35840
yes
no
Details
200-066-2
50-81-7
101
36000
yes
no
Details
227-265-7
5743-36-2
489
41040
yes
no
Details
207-938-1
502-44-3
342
14260
no
no
Details
209-530-9
584-09-8
353
42480
yes
no
12 mg/kg
Details
611-185-8
54686-97-4
752
39890
yes
no
Details
260-414-4
56875-68-4
736
50960
yes
no
Details
225-863-2
5124-30-1
485
15700
13560
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
260-829-0
57583-35-4
698
49595
yes
no
Details
227-534-9
5873-54-1
490
16600
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
-
5136-44-7
486
54005
yes
no
Details
200-001-8
50-00-0
98
17260
54880
yes
no
Details
200-075-1
50-99-7
102
17530
no
no
Details
200-289-5
56-81-5
103
18100
55920
yes
no
Details
261-327-4
58561-47-0
52
56580
yes
no
Details
200-311-3
57-09-0
104
58960
yes
no
6 mg/kg
Details
200-018-0
50-21-5
99
19460
62960
yes
no
Details
209-180-7
557-59-5
350
63920
yes
no
Details
-
54276-35-6
694
21400
no
no
0.05 mg/kg
Details
209-548-7
585-07-9
355
20170
no
no
Details
260-828-5
57583-34-3
697
67515
yes
no
Details
259-374-0
54849-38-6
695
67520
yes
no
Details
208-875-2
544-63-8
348
67891
22350
yes
no
Details
226-864-0
5518-18-3
488
53440
yes
no
Details
200-312-9
57-10-3
105
22780
70400
yes
no
Details
680-272-0
51798-33-5
860
71980
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
258-053-2
52628-03-2
1082
no
no
0.05 mg/kg
Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.
Details
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
Details
258-994-9
54140-20-4
693
88160
yes
no
Details
200-061-5
50-70-4
100
88320
24490
yes
no
Details
200-313-4
57-11-4
106
24550
89040
yes
no
Details
261-257-4
58446-52-9
699
90720
yes
no
Details
200-334-9
57-50-1
108
24880
no
no
Details
260-815-4
57569-40-1
696
92205
yes
no
Details
208-432-3
528-44-9
347
25540
13050
no
no
Details
209-008-0
552-30-7
349
25550
no
no
Details
200-315-5
57-13-6
107
25960
no
no
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
211-471-9
646-25-3
863
15260
no
no
0.05 mg/kg
Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.
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
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
228-229-3
6182-11-2
491
82720
yes
no
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
211-492-3
652-67-5
364
15404
no
no
5 mg/kg
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
Details
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details

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