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 01 December 2021. Database contains 1072 unique substances/entries.
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204-872-5
127-91-3
314
23500
no
no
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231-493-2
7585-39-9
503
46080
yes
no
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201-291-9
80-56-8
155
23470
no
no
view-details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
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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).
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641-029-4
156065-00-8
874
16265
no
no
0.05 mg/kg
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).
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233-007-4
10016-20-3
580
46070
yes
no
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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
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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
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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
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234-394-2
11138-66-2
596
95935
yes
no
view-details
-
-
96
95920
yes
no
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237-772-5
13983-17-0
613
95905
yes
no
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-
-
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
95855
26360
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
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201-081-7
78-08-0
142
26305
no
no
0.05 mg/kg
Only to be used as a surface treatment agent.
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200-867-7
75-38-7
132
26140
no
no
5 mg/kg
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200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
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200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
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406-060-8
110638-71-6
757
95725
yes
no
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200-315-5
57-13-6
107
25960
no
no
view-details
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
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246-466-0
24800-44-0
634
25910
no
no
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203-812-5
110-88-3
255
25900
no
no
5 mg/kg
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.
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-
-
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.
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-
-
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
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
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208-432-3
528-44-9
347
25540
13050
no
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.
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-
-
92
93970
yes
no
0.05 mg/kg
view-details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
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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.
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-
-
5
25360
no
no
0.01 mg/kg
1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
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-
-
6
25380
no
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.
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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.
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-
-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
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-
-
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
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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
203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
view-details
204-126-9
116-14-3
281
25120
no
no
0.05 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
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
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
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.
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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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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
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
248-104-7
26914-43-2
656
24760
no
no
0.05 mg/kg
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
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.
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232-391-0
8013-07-8
532
88640
yes
no
view-details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
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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

export-type