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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212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
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203-968-4
112-41-4
268
16704
no
no
0.05 mg/kg
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214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
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214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
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211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
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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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201-245-8
80-05-7
151
13480
13607
no
no
0.05 mg/kg
Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union].
Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].
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253-781-7
38103-06-9
687
13530
13614
no
no
0.05 mg/kg
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225-306-3
4767-03-7
484
13395
no
no
0.05 mg/kg
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204-781-0
126-30-7
310
16390
22437
no
no
0.05 mg/kg
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219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
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209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
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212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
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CG 30-1577
411-380-6
147315-50-2
770
51700
yes
no
0.05 mg/kg
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239-268-0
15214-89-8
617
10660
no
no
0.05 mg/kg
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201-851-2
88-68-6
164
34895
yes
no
0.05 mg/kg
Only for use in PET for water and beverages.
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205-483-3
141-43-5
326
35170
12763
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.
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228-250-8
6197-30-4
492
45650
yes
no
0.05 mg/kg
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226-029-0
5232-99-5
487
45640
yes
no
0.05 mg/kg
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455-890-7
6607-41-6
872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
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229-962-1
6864-37-5
498
16210
no
no
0.05 mg/kg
Only to be used in polyamides.
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430-800-9
129228-21-3
763
39925
yes
yes
0.05 mg/kg
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3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
862
15180
no
no
0.05 mg/kg
SML including the hydrolysis product 3,4- dihydroxy-1-butene.
Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.
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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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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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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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204-179-8
117-21-5
786
14627
no
no
0.05 mg/kg
SML expressed as 3-chlorophthalic acid.
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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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216-245-3
1533-45-5
422
38515
yes
yes
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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206-466-3
345-92-6
337
15820
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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402-130-7
106246-33-7
755
21765
no
no
0.05 mg/kg
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431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
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216-847-6
1679-51-2
427
18896
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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209-968-0
599-64-4
358
14841
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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202-679-0
98-54-4
186
14020
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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223-578-8
3965-55-7
471
24888
no
no
0.05 mg/kg
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240-759-7
16712-64-4
624
18897
no
no
0.05 mg/kg
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682-678-3
182121-12-6
779
39815
yes
yes
0.05 mg/kg
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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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203-080-7
103-11-7
206
11500
no
no
0.05 mg/kg
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213-663-8
999-61-1
385
11530
no
no
0.05 mg/kg
SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester.
It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).
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681-637-7
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
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235-697-2
12542-30-2
605
11005
no
no
0.05 mg/kg
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218-463-4
2156-97-0
437
11245
no
no
0.05 mg/kg
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293-728-5
91082-17-6
884
34240
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.
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