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 23 September 2021. Database contains 1072 unique substances/entries.
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204-872-5
127-91-3
314
23500
no
no
view-details
231-493-2
7585-39-9
503
46080
yes
no
view-details
201-291-9
80-56-8
155
23470
no
no
view-details
641-029-4
156065-00-8
874
16265
no
no
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
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
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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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
402
96240
yes
no
view-details
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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231-791-2
7732-18-5
515
95855
26360
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
200-315-5
57-13-6
107
25960
no
no
view-details
246-466-0
24800-44-0
634
25910
no
no
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.
view-details
927-697-2
28931-67-1
664
95000
yes
no
view-details
219-547-3
2459-10-1
971
25885
no
no
Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.
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209-008-0
552-30-7
349
25550
no
no
view-details
208-432-3
528-44-9
347
25540
13050
no
no
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
203-048-2
102-70-5
205
25385
no
no
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.
Only to be used in hydrogels intended for non-direct food contact use.
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.
view-details
-
-
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.
view-details
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
203-989-9
112-60-7
269
25090
92350
yes
no
view-details
204-411-8
120-61-6
288
24970
no
no
view-details
260-815-4
57569-40-1
696
92205
yes
no
view-details
229-176-9
6422-86-2
798
92200
yes
no
view-details
202-829-5
100-20-9
191
24940
no
no
view-details
202-830-0
100-21-0
785
24910
no
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
270-337-8
68425-17-2
724
24903
no
no
In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].
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235-819-4
12777-87-6
521
58320
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
204-772-1
126-14-7
309
91360
yes
no
view-details
204-771-6
126-13-6
308
91200
yes
no
view-details
200-334-9
57-50-1
108
24880
no
no
view-details
203-570-0
108-30-5
233
24850
no
no
view-details
203-740-4
110-15-6
247
90960
24820
yes
no
view-details
202-851-5
100-42-5
193
24610
no
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
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).
232-274-4
8001-22-7
524
24520
no
no
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
215-211-5
1313-82-2
401
24475
no
no
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
215-683-2
1343-98-2
417
85680
yes
no
view-details
-
-
85
85610
yes
no
view-details
-
-
84
85601
yes
no
view-details
219-882-5
2561-88-8
450
24430
no
no
view-details
203-672-5
109-43-3
242
85360
yes
no
view-details
203-845-5
111-20-6
260
24280
no
no
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 tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
539
24160
no
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
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
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
204-062-1
115-07-1
275
23980
no
no
view-details
204-638-2
123-62-6
297
23950
no
no
view-details
203-293-5
105-38-4
211
23920
no
no
view-details
201-176-3
79-09-4
146
82000
23890
yes
no
view-details
204-623-0
123-38-6
296
23860
no
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.].
view-details
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
680-598-3
70142-34-6
737
77370
yes
no
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
-
-
75
77702
yes
no
view-details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
view-details
618-339-3
9002-88-4
549
80000
yes
no
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
-
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
700-107-9
87189-25-1
751
81515
yes
no
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
-
147398-31-0
1059
no
no
Only to be used either alone or blended with other polymers in contact with all foods under contact conditions of up to 6 months and/or 6 months and more, at room temperature or below, including hot fill or a short heating up phase.
The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food.
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
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
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
201-873-2
88-99-3
165
23200
74480
yes
no
view-details
201-873-2
88-99-3
192
23187
no
no
view-details
250-709-6
31570-04-4
671
74240
yes
no
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.
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
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
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
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
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
203-692-4
109-66-0
244
71720
yes
no
view-details
229-722-6
6683-19-8
496
71680
yes
no
view-details
204-104-9
115-77-5
279
22840
71600
yes
no
view-details
232-553-0
9000-69-5
546
71440
yes
no
view-details
206-765-9
373-49-9
338
71020
yes
no
view-details
203-829-8
111-06-8
258
70480
yes
no
view-details
200-312-9
57-10-3
105
22780
70400
yes
no
view-details
202-804-9
99-96-7
190
18880
no
no
view-details
203-398-6
106-44-5
216
14770
no
no
view-details
680-864-9
12198-93-5
602
70240
yes
no
view-details
205-597-3
143-28-2
332
69760
yes
no
view-details
204-007-1
112-80-1
270
69040
22763
yes
no
view-details
206-103-9
301-02-0
335
68960
yes
no
view-details
204-019-7
112-96-9
274
22570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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202-423-8
95-48-7
174
14740
no
no
view-details
618-392-2
9004-70-0
562
22450
no
no
view-details
609-369-8
37244-96-5
684
68125
yes
no
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.
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-
66822-60-4
719
65920
yes
no
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export-type