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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201-770-2
87-78-5
162
65520
yes
no
view-details
-
37206-01-2
683
66200
yes
no
view-details
618-391-7
9004-67-5
561
66240
yes
no
view-details
-
9004-59-5
557
66640
yes
no
view-details
-
-
64
66695
yes
no
view-details
618-389-6
9004-65-3
560
66700
yes
no
view-details
614-610-5
68554-70-1
730
66930
yes
no
Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.
view-details
601-648-2
12001-26-2
597
67120
yes
no
view-details
-
-
65
67155
yes
no
Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation).
Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %)
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288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
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215-263-9
1317-33-5
404
67200
yes
no
view-details
266-836-5
67649-65-4
720
67360
yes
no
view-details
248-227-6
27107-89-7
657
67680
yes
no
view-details
-
-
66
67600
yes
no
view-details
247-665-5
26401-86-5
645
67760
yes
no
view-details
260-828-5
57583-34-3
697
67515
yes
no
view-details
259-374-0
54849-38-6
695
67520
yes
no
view-details
Wax obtained by extraction of lignite.
232-313-5
8002-53-7
529
67850
yes
no
view-details
-
-
67
67840
yes
no
view-details
-
-
1030
yes
no
0.05 mg/kg
Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below.
The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food.
Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
view-details
-
-
1075
yes
no
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
view-details
208-875-2
544-63-8
348
67891
22350
yes
no
view-details
401-990-0
106990-43-6
791
92470
yes
no
0.05 mg/kg
view-details
481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
view-details
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
view-details
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
795
40155
yes
no
0.05 mg/kg
view-details
-
61269-61-2
701
40160
yes
no
2.4 mg/kg
view-details
251-156-3
32687-78-8
675
38800
yes
yes
15 mg/kg
view-details
-
153250-52-3
772
47500
yes
no
5 mg/kg
view-details
203-004-2
102-08-9
200
51680
yes
yes
3 mg/kg
view-details
203-756-1
110-31-6
251
53360
yes
no
view-details
226-864-0
5518-18-3
488
53440
yes
no
view-details
203-755-6
110-30-5
250
53520
yes
no
view-details
203-041-4
102-60-3
204
25180
92640
yes
no
view-details
-
-
19
39090
yes
no
view-details
-
-
20
39120
yes
no
SML(T) expressed excluding HCl.
view-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.
view-details
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
view-details
203-867-5
111-41-1
262
35284
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.
For indirect food contact only, behind a PET layer.
view-details
-
-
14
33801
yes
no
30 mg/kg
view-details
206-376-4
334-48-5
336
45940
15095
yes
no
view-details
-
66822-60-4
719
65920
yes
no
view-details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
view-details
225-218-5
4724-48-5
483
68860
yes
no
0.05 mg/kg
view-details
248-093-9
26896-20-8
819
68110
yes
no
0.05 mg/kg
Not to be used in polymers contacting fatty foods.
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
SML expressed as neodecanoic acid.
view-details
-
-
810
68119
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
-
-
810
68119
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
view-details
609-369-8
37244-96-5
684
68125
yes
no
view-details
218-216-0
2082-79-3
433
68320
yes
yes
6 mg/kg
view-details
233-226-5
10094-45-8
587
68400
yes
yes
5 mg/kg
view-details
206-103-9
301-02-0
335
68960
yes
no
view-details
204-007-1
112-80-1
270
69040
22763
yes
no
view-details
205-597-3
143-28-2
332
69760
yes
no
view-details
240-367-6
16260-09-6
622
69840
yes
yes
5 mg/kg
view-details
205-634-3
144-62-7
333
69920
22775
yes
no
6 mg/kg
view-details
680-864-9
12198-93-5
602
70240
yes
no
view-details
271-867-2
68610-51-5
732
45450
yes
yes
5 mg/kg
view-details
200-312-9
57-10-3
105
70400
22780
yes
no
view-details
203-829-8
111-06-8
258
70480
yes
no
view-details
206-765-9
373-49-9
338
71020
yes
no
view-details
232-553-0
9000-69-5
546
71440
yes
no
view-details
204-104-9
115-77-5
279
22840
71600
yes
no
view-details
246-665-2
25151-96-6
637
71635
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.
view-details
429-160-3
178671-58-4
778
71670
yes
yes
0.05 mg/kg
view-details
229-722-6
6683-19-8
496
71680
yes
no
view-details
203-692-4
109-66-0
244
71720
yes
no
view-details
-
-
822
71938
yes
no
0.002 mg/kg
view-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.
view-details
700-323-3
908020-52-0
926
71955
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
view-details
236-236-8
13252-13-6
861
71990
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.
view-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.
view-details
223-320-4
3825-26-1
468
71960
yes
no
Only to be used in repeated use articles, sintered at high temperatures.
view-details
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.
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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231-633-2
7664-38-2
509
23170
72640
yes
no
view-details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
view-details
-
-
68
73160
yes
yes
0.05 mg/kg
view-details
204-118-5
115-96-8
280
73720
yes
no
0.01 mg/kg
view-details
416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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.
view-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.
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.
view-details
250-709-6
31570-04-4
671
74240
yes
no
view-details
-
-
69
74400
yes
yes
30 mg/kg
view-details
201-873-2
88-99-3
165
23200
74480
yes
no
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
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
201-557-4
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
-
-
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
-
-
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
201-607-5
85-44-9
158
23380
76320
yes
no
view-details
-
-
820
76420
yes
no
view-details
618-355-0
9003-11-6
551
79920
yes
no
view-details
923-642-1
106392-12-5
551
79920
yes
no
view-details
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
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
-
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
-
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
700-107-9
87189-25-1
751
81515
yes
no
view-details
606-265-4
192268-64-7
780
81220
yes
no
5 mg/kg
view-details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
view-details
-
-
70
76463
yes
no
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
-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
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
-
-
71
76730
yes
no
6 mg/kg
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
843-673-3
73018-26-5
797
76807
yes
yes
view-details
843-673-3
73018-26-5
797
76807
yes
yes
view-details
-
-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
view-details
-
-
73
76866
yes
yes
view-details
-
-
73
76866
yes
yes
view-details
-
-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
view-details
618-339-3
9002-88-4
549
80000
yes
no
view-details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
view-details
1 - 4.5 moles ethoxylated
500-038-2
25322-68-3
638
23590
76960
yes
no
view-details
-
-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
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
-
-
78
77897
yes
no
5 mg/kg
view-details
-
-
74
77440
yes
yes
42 mg/kg
view-details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
view-details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
view-details
-
-
75
77702
yes
no
view-details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
view-details
1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
view-details
1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
view-details
618-421-9
9005-66-7
570
79200
yes
no
view-details
1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
view-details
618-422-4
9005-70-3
572
79360
yes
no
view-details
618-424-5
9005-71-4
573
79440
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
680-598-3
70142-34-6
737
77370
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
608-428-5
29894-35-7
668
80240
yes
no
view-details
-
-
79
80640
yes
no
view-details
232-417-0
8017-16-1
534
80720
yes
no
view-details
618-352-4
9003-07-0
550
81060
yes
no
view-details
1 - 4.5 moles propoxylated
500-039-8
25322-69-4
639
23651
80800
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.].
view-details
231-830-3
7758-02-3
517
81520
yes
no
view-details
215-181-3
1310-58-3
399
81600
yes
no
view-details
231-659-4
7681-11-0
512
81680
yes
no
view-details
-
-
80
81760
yes
no
view-details
201-176-3
79-09-4
146
82000
23890
yes
no
view-details
-
-
81
83320
yes
no
view-details
-
-
82
83325
yes
no
view-details
-
-
83
83330
yes
no
view-details
219-574-0
2466-09-3
445
83440
yes
no
view-details
-
13445-56-2
609
83455
yes
no
view-details
602-803-7
12269-78-2
603
83460
yes
no
view-details
238-878-4
14808-60-7
616
83470
yes
no
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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270-476-4
68442-12-6
726
83599
yes
yes
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277-299-1
73138-82-6
741
83610
24070
yes
no
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205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
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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
232-482-5
8050-31-5
538
84000
yes
no
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232-479-9
8050-26-8
537
84080
yes
no
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266-041-3
65997-06-0
717
84210
yes
no
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266-042-9
65997-13-9
718
84240
yes
no
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232-476-2
8050-15-5
536
84320
yes
no
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264-848-5
64365-17-9
714
84400
yes
no
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232-689-0
9006-04-6
574
24250
84560
yes
no
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200-712-3
69-72-7
121
84640
24270
yes
no
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201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
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204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
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203-672-5
109-43-3
242
85360
yes
no
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-
-
84
85601
yes
no
view-details
-
-
85
85610
yes
no
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215-683-2
1343-98-2
417
85680
yes
no
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-
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
-
-
86
86000
yes
no
view-details
206-991-8
409-21-2
339
86160
yes
no
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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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-
-
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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231-548-0
7631-90-5
505
86480
yes
no
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231-599-9
7647-15-6
508
86560
yes
no
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215-185-5
1310-73-2
400
86720
yes
no
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231-679-3
7681-82-5
513
86800
yes
no
view-details
-
-
88
86880
yes
no
9 mg/kg
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231-555-9
7632-00-0
506
86920
yes
no
0.6 mg/kg
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231-821-4
7757-83-7
516
86960
yes
no
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215-540-4
1330-43-4
407
87040
yes
no
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231-867-5
7772-98-7
519
87120
yes
no
view-details
203-768-7
110-44-1
252
87200
yes
no
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249-448-0
29116-98-1
666
87280
yes
no
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263-600-3
62568-11-0
709
87520
yes
no
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215-663-3
1338-39-2
414
87600
yes
no
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215-665-4
1338-43-8
416
87680
yes
no
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247-568-8
26266-57-9
643
87760
yes
no
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215-664-9
1338-41-6
415
87840
yes
no
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262-958-8
61752-68-9
702
87920
yes
no
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247-569-3
26266-58-0
644
88080
yes
no
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258-994-9
54140-20-4
693
88160
yes
no
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export-type