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 03 December 2021. Database contains 1072 unique substances/entries.
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223-773-8
4066-02-8
472
66560
yes
yes
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274-572-7
70331-94-1
739
70000
yes
no
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221-140-0
3010-96-6
881
25187
no
no
5 mg/kg
Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
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229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
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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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216-823-5
1675-54-3
426
13610
13510
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
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253-781-7
38103-06-9
687
13614
13530
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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203-615-4
108-78-1
239
25420
19975
93720
yes
no
2.5 mg/kg
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213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
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200-254-4
56-06-4
864
46330
yes
no
5 mg/kg
Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.
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202-095-6
91-76-9
168
13075
15310
no
no
5 mg/kg
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205-029-4
131-56-6
318
48640
yes
no
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209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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230-426-4
7128-64-5
500
38560
yes
yes
0.6 mg/kg
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223-945-2
4130-42-1
477
46720
yes
yes
4.8 mg/kg
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204-881-4
128-37-0
315
46640
yes
no
3 mg/kg
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209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
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214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
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212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
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202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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223-445-4
3896-11-5
470
60400
yes
yes
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223-383-8
3864-99-1
469
60480
yes
yes
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219-470-5
2440-22-4
444
61440
yes
no
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257-624-3
52047-59-3
692
52320
yes
yes
0.06 mg/kg
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274-570-6
70321-86-7
738
60320
yes
yes
1.5 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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203-452-9
107-01-7
224
13900
no
no
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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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245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
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203-234-3
104-76-7
209
17050
no
no
30 mg/kg
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205-031-5
131-57-7
319
61360
yes
yes
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217-421-2
1843-05-6
431
61600
yes
yes
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201-143-3
78-79-5
144
19243
21640
no
no
0.01 mg/kg
1 mg/kg in final product.
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220-239-6
2682-20-4
451
66755
yes
no
0.5 mg/kg
Only to be used in aqueous polymer dispersions and emulsions.
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213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
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200-661-7
67-63-0
118
23830
81882
yes
no
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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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202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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256-318-7
47465-97-4
691
13600
no
no
1.8 mg/kg
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224-166-0
4221-80-1
480
46790
yes
no
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267-342-2
67845-93-6
721
46800
yes
no
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221-532-1
3135-18-0
459
46870
yes
no
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265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
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