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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203-545-4
108-05-4
231
10120
no
no
12 mg/kg
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205-500-4
141-78-6
327
30140
yes
no
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204-658-1
123-86-4
300
30045
yes
no
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200-580-7
64-19-7
115
30000
10090
yes
no
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200-836-8
75-07-0
128
10060
no
no
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208-178-3
514-10-3
346
10030
no
no
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219-785-8
2530-85-0
788
21498
no
no
0.05 mg/kg
Only to be used as a surface treatment agent of inorganic fillers.
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219-784-2
2530-83-8
1068
no
no
Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).
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682-678-3
182121-12-6
779
39815
yes
yes
0.05 mg/kg
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-
-
27
48960
yes
no
5 mg/kg
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204-432-2
120-87-6
27
48960
yes
no
5 mg/kg
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222-067-7
3333-62-8
465
68040
yes
no
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240-759-7
16712-64-4
624
18897
no
no
0.05 mg/kg
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229-662-0
6642-31-5
495
35160
yes
no
5 mg/kg
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-
-
823
24889
no
no
5 mg/kg
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223-578-8
3965-55-7
471
24888
no
no
0.05 mg/kg
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240-347-7
16219-75-3
621
17110
no
no
0.05 mg/kg
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-
-
26
46700
yes
no
5 mg/kg
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202-679-0
98-54-4
186
14020
no
no
0.05 mg/kg
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211-720-1
691-37-2
366
22150
no
no
0.05 mg/kg
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202-307-7
94-13-3
173
60240
yes
no
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202-785-7
99-76-3
189
60200
yes
no
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224-069-3
4191-73-5
478
60180
yes
no
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204-399-4
120-47-8
287
60160
yes
no
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245-818-0
23676-09-7
632
52880
yes
no
3.6 mg/kg
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209-968-0
599-64-4
358
14841
no
no
0.05 mg/kg
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204-251-9
118-45-6
787
14628
no
no
0.05 mg/kg
SML expressed as 4-chlorophthalic acid.
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216-847-6
1679-51-2
427
18896
no
no
0.05 mg/kg
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202-525-2
96-69-5
178
92800
yes
yes
0.48 mg/kg
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431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
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402-130-7
106246-33-7
755
21765
no
no
0.05 mg/kg
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201-250-5
80-09-1
154
13617
16090
no
no
0.05 mg/kg
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202-200-5
92-88-6
170
16000
no
no
6 mg/kg
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210-288-1
611-99-4
359
48720
15970
yes
no
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206-466-3
345-92-6
337
15820
no
no
0.05 mg/kg
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201-247-9
80-07-9
152
15610
no
no
0.05 mg/kg
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201-248-4
80-08-0
153
15267
no
no
5 mg/kg
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235-841-4
13003-12-8
608
40800
yes
yes
6 mg/kg
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216-245-3
1533-45-5
422
38515
yes
yes
0.05 mg/kg
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-
958445-44-8
896
71958
yes
no
Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.
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209-249-1
563-45-1
351
21730
no
no
0.01 mg/kg
Only to be used in polypropylene.
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224-709-1
4457-71-0
883
22074
no
no
0.05 mg/kg
Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg.
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616-996-0
80181-31-3
744
18888
no
no
The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.
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204-179-8
117-21-5
786
14627
no
no
0.05 mg/kg
SML expressed as 3-chlorophthalic acid.
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209-929-8
598-32-3
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
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213-048-4
919-30-2
377
12786
no
no
0.05 mg/kg
Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers.
SML = 0,05 mg/kg when used for the surface treatment of materials and articles.
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236-946-8
13560-49-1
611
35120
yes
no
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ANOX 1315; ANOX BF; DURAD AX 38
413-750-2
171090-93-0
895
47060
yes
no
0.05 mg/kg
Only to be used in polyolefins in contact with foods other than fatty/ high-alcoholic and dairy products.
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410-730-5
90498-90-1
858
38565
yes
yes
0.05 mg/kg
SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer.
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265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
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