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 28 March 2024. Database contains 1080 unique substances/entries.
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IRGAFOS 38
416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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
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
213-663-8
999-61-1
385
11530
no
no
0.05 mg/kg
SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester.
It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).
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
-
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
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
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
3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
862
15180
no
no
0.05 mg/kg
SML including the hydrolysis product 3,4- dihydroxy-1-butene.
Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.
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
-
-
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
618-128-6
882073-43-0
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
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
-
-
20
39120
yes
no
SML(T) expressed excluding HCl.
Details
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
Details
-
-
805
93450
yes
no
The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w.
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
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
-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
Details
-
167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
Details
-
-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
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
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
-
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
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
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
618-363-4
9003-39-8
552
81500
yes
no
The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC [OJ L 253, 20.9.2008, p. 1.].
Details
607-759-2
25618-55-7
1017
yes
no
To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
Details
455-890-7
6607-41-6
872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
Details
613-156-5
63148-62-9
575
76721
yes
no
Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).
Details
203-027-8
102-39-6
202
23070
no
no
0.05 mg/kg
Details
617-241-8
81541-12-0
752
39890
yes
no
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
Details
221-950-4
3290-92-4
463
25840
no
no
0.05 mg/kg
Details
217-420-7
1843-03-4
430
95600
yes
yes
5 mg/kg
Details
252-816-3
35958-30-6
679
39060
yes
yes
5 mg/kg
Details
200-866-1
75-37-6
131
48460
yes
no
Details
500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
Details
431-890-2
166412-78-8
775
45705
yes
no
Details
204-427-5
120-80-9
289
24051
15880
no
no
6 mg/kg
Details
200-338-0
57-55-6
109
23740
81840
yes
no
Details
618-414-0
9005-37-2
567
82080
yes
no
Details
245-217-3
22788-19-8
630
82240
yes
no
Details
203-315-3
105-62-4
213
82400
yes
no
Details
251-581-4
33587-20-1
677
82560
yes
no
Details
228-229-3
6182-11-2
491
82720
yes
no
Details
248-315-4
27194-74-7
659
82800
yes
no
Details
215-549-3
1330-80-9
408
82960
yes
no
Details
249-369-1
29013-28-3
665
83120
yes
no
Details
215-354-3
1323-39-3
406
83300
yes
no
Details
216-971-0
1709-70-2
428
95200
yes
no
Details
456-830-2
745070-61-5
784
95420
yes
no
5 mg/kg
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
254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
Details
216-032-5
1477-55-0
421
13000
no
no
Details
203-028-3
102-40-9
203
13323
no
no
0.05 mg/kg
Details
203-529-7
107-88-0
228
13690
no
no
Details
203-585-2
108-46-3
237
24072
15910
no
no
2.4 mg/kg
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
203-584-7
108-45-2
236
23050
no
no
0.01 mg/kg
Details
207-997-3
504-63-2
343
23770
no
no
0.05 mg/kg
Details
203-268-9
105-08-8
210
13390
14880
no
no
Details
203-786-5
110-63-4
254
40580
13720
yes
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
0.05 mg/kg
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
203-782-3
110-60-1
253
15250
no
no
Details
203-400-5
106-46-7
217
15565
no
no
12 mg/kg
Details
204-617-8
123-31-9
295
48620
15940
18867
yes
no
0.6 mg/kg
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
Details
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
216-711-6
1647-16-1
424
15070
no
no
0.05 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
223-805-0
4080-31-3
474
43600
yes
no
0.3 mg/kg
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
200-751-6
71-36-3
123
13840
no
no
Details
203-449-2
106-98-9
222
13870
no
no
Details
203-956-9
112-30-1
267
15100
no
no
Details
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
203-968-4
112-41-4
268
16704
no
no
0.05 mg/kg
Details
253-149-0
36653-82-4
681
18310
no
no
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
205-583-7
143-08-8
331
22480
no
no
Details
203-917-6
111-87-5
265
22600
no
no
Details
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
200-752-1
71-41-0
124
22870
no
no
Details
203-694-5
109-67-1
245
22900
no
no
5 mg/kg
Details
200-746-9
71-23-8
122
23800
no
no
Details
214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
Details
214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
Details
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
203-366-1
106-14-9
214
61840
yes
no
Details
205-026-8
131-53-3
317
48880
yes
yes
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
403-020-1
118337-09-0
759
54300
yes
yes
6 mg/kg
Details

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