plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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 30 July 2021. Database contains 1072 unique substances/entries.
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231-493-2
7585-39-9
503
46080
yes
no
view-details
233-007-4
10016-20-3
580
46070
yes
no
view-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.
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215-251-3
1314-98-3
403
96320
yes
no
view-details
215-222-5
1314-13-2
402
96240
yes
no
view-details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
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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.
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243-814-3
20427-58-1
628
96190
yes
no
view-details
234-394-2
11138-66-2
596
95935
yes
no
view-details
-
-
96
95920
yes
no
view-details
237-772-5
13983-17-0
613
95905
yes
no
view-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)
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-
-
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)
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-
-
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).
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231-791-2
7732-18-5
515
26360
95855
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
view-details
406-060-8
110638-71-6
757
95725
yes
no
view-details
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
view-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.
view-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.
view-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.
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927-697-2
28931-67-1
664
95000
yes
no
view-details
204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
view-details
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
view-details
203-953-2
112-27-6
266
25510
94320
yes
no
view-details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
view-details
203-049-8
102-71-6
793
94000
yes
no
0.05 mg/kg
SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine.
view-details
-
-
92
93970
yes
no
0.05 mg/kg
view-details
201-067-0
77-90-7
138
93760
yes
no
view-details
232-552-5
9000-65-1
545
93680
yes
no
view-details
257-757-7
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
view-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.
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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.
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-
-
805
93450
yes
no
The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w.
view-details
-
-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
view-details
-
-
873
93460
yes
no
Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
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236-675-5
13463-67-7
610
93440
yes
no
view-details
240-613-2
16545-54-3
894
93360
yes
no
view-details
211-750-5
693-36-7
368
93280
yes
yes
view-details
204-614-1
123-28-4
294
93120
yes
yes
view-details
-
120218-34-0
761
92930
yes
no
6 mg/kg
view-details
255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
view-details
254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
view-details
203-989-9
112-60-7
269
25090
92350
yes
no
view-details
-
-
91
92320
yes
yes
15 mg/kg
view-details
246-563-8
25013-16-5
635
40720
yes
no
30 mg/kg
view-details
260-815-4
57569-40-1
696
92205
yes
no
view-details
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
view-details
229-176-9
6422-86-2
798
92200
yes
no
view-details
-
-
90
92195
yes
no
view-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.
view-details
238-877-9
14807-96-6
615
92080
yes
no
view-details
231-639-5
7664-93-9
511
91920
yes
no
view-details
231-722-6
7704-34-9
514
91840
yes
no
view-details
-
-
814
91815
yes
no
2 mg/kg
view-details
-
-
813
91530
yes
no
5 mg/kg
view-details
204-772-1
126-14-7
309
91360
yes
no
view-details
204-771-6
126-13-6
308
91200
yes
no
view-details
203-740-4
110-15-6
247
90960
24820
yes
no
view-details
261-257-4
58446-52-9
699
90720
yes
no
view-details
-
-
821
90810
yes
no
view-details
-
-
89
89440
yes
no
view-details
204-666-5
123-95-5
301
89120
yes
no
view-details
200-313-4
57-11-4
106
24550
89040
yes
no
view-details
204-693-2
124-26-5
306
88960
yes
no
view-details
686-629-7
68412-29-3
723
88880
yes
no
view-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
88800
24540
yes
no
view-details
232-391-0
8013-07-8
532
88640
yes
no
view-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.
view-details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
view-details
248-027-9
26836-47-5
654
88600
yes
no
view-details
200-061-5
50-70-4
100
88320
24490
yes
no
view-details
247-891-4
26658-19-5
651
88240
yes
no
view-details
258-994-9
54140-20-4
693
88160
yes
no
view-details
247-569-3
26266-58-0
644
88080
yes
no
view-details
262-958-8
61752-68-9
702
87920
yes
no
view-details
215-664-9
1338-41-6
415
87840
yes
no
view-details
247-568-8
26266-57-9
643
87760
yes
no
view-details
215-665-4
1338-43-8
416
87680
yes
no
view-details
215-663-3
1338-39-2
414
87600
yes
no
view-details
263-600-3
62568-11-0
709
87520
yes
no
view-details
249-448-0
29116-98-1
666
87280
yes
no
view-details
203-768-7
110-44-1
252
87200
yes
no
view-details
231-867-5
7772-98-7
519
87120
yes
no
view-details
215-540-4
1330-43-4
407
87040
yes
no
view-details
231-821-4
7757-83-7
516
86960
yes
no
view-details
231-555-9
7632-00-0
506
86920
yes
no
0.6 mg/kg
view-details
-
-
88
86880
yes
no
9 mg/kg
view-details
231-679-3
7681-82-5
513
86800
yes
no
view-details
215-185-5
1310-73-2
400
86720
yes
no
view-details
231-599-9
7647-15-6
508
86560
yes
no
view-details
231-548-0
7631-90-5
505
86480
yes
no
view-details
-
-
87
86285
yes
no
For synthetic amorphous silicon dioxide, silanated: primary particles of 1-100 nm which are aggregated to a size of 0,1-1 µm and may form agglomerates within the size distribution of 0,3 µm to the mm size.
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231-545-4
7631-86-9
504
86240
yes
no
For synthetic amorphous silicon dioxide: primary particles of 1 - 100 nm which are aggregated to a size of 0,1 - 1 µm which may form agglomerates within the size distribution of 0,3 µm to the mm size.
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206-991-8
409-21-2
339
86160
yes
no
view-details
-
-
86
86000
yes
no
view-details
-
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.
view-details
215-683-2
1343-98-2
417
85680
yes
no
view-details
-
-
85
85610
yes
no
view-details
-
-
84
85601
yes
no
view-details
203-672-5
109-43-3
242
85360
yes
no
view-details
204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
view-details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
view-details
200-712-3
69-72-7
121
84640
24270
yes
no
view-details
232-689-0
9006-04-6
574
24250
84560
yes
no
view-details
264-848-5
64365-17-9
714
84400
yes
no
view-details
232-476-2
8050-15-5
536
84320
yes
no
view-details
266-042-9
65997-13-9
718
84240
yes
no
view-details
266-041-3
65997-06-0
717
84210
yes
no
view-details
232-479-9
8050-26-8
537
84080
yes
no
view-details
232-482-5
8050-31-5
538
84000
yes
no
view-details
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
535
24100
24190
83840
24130
yes
no
view-details
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
view-details
277-299-1
73138-82-6
741
83610
24070
yes
no
view-details
270-476-4
68442-12-6
726
83599
yes
yes
view-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.
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238-878-4
14808-60-7
616
83470
yes
no
view-details
602-803-7
12269-78-2
603
83460
yes
no
view-details
-
13445-56-2
609
83455
yes
no
view-details
219-574-0
2466-09-3
445
83440
yes
no
view-details
-
-
83
83330
yes
no
view-details
-
-
82
83325
yes
no
view-details
-
-
81
83320
yes
no
view-details
201-176-3
79-09-4
146
82000
23890
yes
no
view-details
-
-
80
81760
yes
no
view-details
231-659-4
7681-11-0
512
81680
yes
no
view-details
215-181-3
1310-58-3
399
81600
yes
no
view-details
231-830-3
7758-02-3
517
81520
yes
no
view-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.].
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1 - 4.5 moles propoxylated
500-039-8
25322-69-4
639
23651
80800
yes
no
view-details
618-352-4
9003-07-0
550
81060
yes
no
view-details
232-417-0
8017-16-1
534
80720
yes
no
view-details
-
-
79
80640
yes
no
view-details
608-428-5
29894-35-7
668
80240
yes
no
view-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.
view-details
680-598-3
70142-34-6
737
77370
yes
no
view-details
618-558-4
9046-01-9
578
79600
yes
no
5 mg/kg
For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
view-details
618-424-5
9005-71-4
573
79440
yes
no
view-details
618-422-4
9005-70-3
572
79360
yes
no
view-details
1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
view-details
618-421-9
9005-66-7
570
79200
yes
no
view-details
1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
view-details
1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
view-details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
view-details
-
-
75
77702
yes
no
view-details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
view-details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
view-details
-
-
74
77440
yes
yes
42 mg/kg
view-details
-
-
78
77897
yes
no
5 mg/kg
view-details
-
-
799
77708
yes
no
1.8 mg/kg
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
view-details
-
-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
view-details
1 - 4.5 moles ethoxylated
500-038-2
25322-68-3
638
23590
76960
yes
no
view-details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
view-details
618-339-3
9002-88-4
549
80000
yes
no
view-details
-
-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
view-details
-
-
73
76866
yes
yes
view-details
-
-
73
76866
yes
yes
view-details
-
-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
view-details
843-673-3
73018-26-5
797
76807
yes
yes
view-details
843-673-3
73018-26-5
797
76807
yes
yes
view-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).
view-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).
view-details
-
-
71
76730
yes
no
6 mg/kg
view-details
-
167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
view-details
-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
view-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).
view-details
-
-
70
76463
yes
no
view-details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
view-details
606-265-4
192268-64-7
780
81220
yes
no
5 mg/kg
view-details
700-107-9
87189-25-1
751
81515
yes
no
view-details
-
90751-07-8
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
view-details
-
1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
view-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.
view-details
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
view-details
923-642-1
106392-12-5
551
79920
yes
no
view-details
618-355-0
9003-11-6
551
79920
yes
no
view-details
-
-
820
76420
yes
no
view-details
201-607-5
85-44-9
158
23380
76320
yes
no
view-details
-
-
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.
view-details
-
-
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.
view-details
-
-
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 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.
view-details
-
-
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 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.
view-details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
view-details
201-557-4
84-74-2
157
74880
yes
no
0.3 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
view-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.
view-details
204-211-0
117-81-7
283
74640
yes
no
1.5 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.
view-details
201-622-7
85-68-7
159
74560
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.
view-details
201-622-7
85-68-7
159
74560
yes
no
30 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 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.
view-details
201-873-2
88-99-3
165
23200
74480
yes
no
view-details
-
-
69
74400
yes
yes
30 mg/kg
view-details
250-709-6
31570-04-4
671
74240
yes
no
view-details
843-672-8
1227937-46-3
1076
yes
no
0.05 mg/kg
Only to be used as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended 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.
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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.
view-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.
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416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
view-details
204-118-5
115-96-8
280
73720
yes
no
0.01 mg/kg
view-details
-
-
68
73160
yes
yes
0.05 mg/kg
view-details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
view-details
231-633-2
7664-38-2
509
23170
72640
yes
no
view-details
-
-
97
72081/10
yes
no
Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.
Properties: Viscosity at 120 °C: > 3 Pa.s,Softening point: > 95 °C as determined by ASTM Method E 28-67,Bromine number: < 40 (ASTM D1159),The colour of a 50 % solution in toluene < 11 on the Gardner scale,Residual aromatic monomer ≤ 50 ppm.
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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.
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export-type