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 15 October 2021. Database contains 1072 unique substances/entries.
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203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
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254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
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255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
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204-614-1
123-28-4
294
93120
yes
yes
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211-750-5
693-36-7
368
93280
yes
yes
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240-613-2
16545-54-3
894
93360
yes
no
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236-675-5
13463-67-7
610
93440
yes
no
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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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257-757-7
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
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232-552-5
9000-65-1
545
93680
yes
no
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201-067-0
77-90-7
138
93760
yes
no
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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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248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
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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.
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212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
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203-953-2
112-27-6
266
25510
94320
yes
no
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253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
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204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
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208-432-3
528-44-9
347
25540
13050
no
no
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209-008-0
552-30-7
349
25550
no
no
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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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203-812-5
110-88-3
255
25900
no
no
5 mg/kg
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246-466-0
24800-44-0
634
25910
no
no
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254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
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200-315-5
57-13-6
107
25960
no
no
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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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200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
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200-867-7
75-38-7
132
26140
no
no
5 mg/kg
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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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220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
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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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237-772-5
13983-17-0
613
95905
yes
no
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234-394-2
11138-66-2
596
95935
yes
no
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243-814-3
20427-58-1
628
96190
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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215-222-5
1314-13-2
402
96240
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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215-251-3
1314-98-3
403
96320
yes
no
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233-007-4
10016-20-3
580
46070
yes
no
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202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
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201-291-9
80-56-8
155
23470
no
no
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231-493-2
7585-39-9
503
46080
yes
no
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204-872-5
127-91-3
314
23500
no
no
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A clay that is essentially kaolinite, a hydrated aluminum silicate. It has a high fusion point and is the most refractory of all clays.
310-194-1
1332-58-7
410
62720
yes
no
Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi- layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.
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405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
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431-890-2
166412-78-8
775
45705
yes
no
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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.
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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.
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485-230-3
1455-42-1
1052
no
no
5 mg/kg
Only to be used as a monomer in the production of polyesters.
The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).
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