plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorized Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation (EU) 2023/1627, OJ L 201, 11 August 2023

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 14 May 2024. Database contains 1080 unique substances/entries.
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202-859-9
100-51-6
194
13150
no
no
Details
219-348-1
2421-28-5
1083
no
no
0.05 mg/kg
Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.
Details
-
4196-95-6
479
12970
no
no
Details
204-669-1
123-99-9
302
12820
no
no
Details
-
-
347
25540
13050
no
no
Details
-
-
655
25450
no
no
0.05 mg/kg
Details
-
-
785
24910
no
no
Details
-
-
656
24760
no
no
0.05 mg/kg
Details
-
-
260
24280
no
no
Details
-
-
192
23187
no
no
Details
-
-
241
22960
no
no
3 mg/kg
Details
-
-
190
18880
no
no
Details
-
-
216
14770
no
no
Details
-
-
174
14740
no
no
Details
-
-
731
18220
no
no
0.05 mg/kg
Details
-
-
367
16697
no
no
Details
-
-
117
21550
no
no
Details
-
-
150
20020
no
no
Details
-
-
235
14710
no
no
Details
-
-
182
19270
no
no
Details
-
-
291
19150
no
no
Details
-
-
278
18250
no
no
0.01 mg/kg
Details
-
-
794
18117
no
no
Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.
Details
-
-
1031
no
no
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.
The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).
Details
-
-
229
14140
no
no
Details
-
-
194
13150
no
no
Details
-
-
302
12820
no
no
Details
-
-
147
10690
no
no
Details
-
-
346
10030
no
no
Details
-
-
186
14020
no
no
0.05 mg/kg
Details
-
-
358
14841
no
no
0.05 mg/kg
Details
-
-
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
-
-
209
17050
no
no
30 mg/kg
Details
-
-
617
10660
no
no
0.05 mg/kg
Details
-
-
389
22360
no
no
5 mg/kg
Details
-
-
352
16360
no
no
0.05 mg/kg
Details
-
-
882
25872
no
no
0.05 mg/kg
Details
-
-
484
13395
no
no
0.05 mg/kg
Details
-
-
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.
Details
-
-
369
12761
no
no
0.05 mg/kg
Details
-
-
443
12788
no
no
5 mg/kg
Details
-
-
122
23800
no
no
Details
-
-
124
22870
no
no
Details
-
-
265
22600
no
no
Details
-
-
331
22480
no
no
Details
-
-
681
18310
no
no
Details
-
-
267
15100
no
no
Details
-
-
123
13840
no
no
Details
-
-
361
18700
no
no
0.05 mg/kg
Details
-
-
364
15404
no
no
5 mg/kg
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
Details
-
-
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
-
-
343
23770
no
no
0.05 mg/kg
Details
-
-
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
-
-
3
12375
no
no
Details
-
-
2
12340
no
no
Details
-
266309-43-7
1
12310
no
no
Details
218-001-1
2035-75-8
432
12280
no
no
Details
223-792-1
4074-90-2
473
12265
no
no
0.01 mg/kg
5 mg/kg in final product.
Only to be used as co-monomer.
Details
203-466-5
107-13-1
225
12100
no
no
0.01 mg/kg
Details
216-768-7
1663-39-4
425
10840
no
no
Details
221-072-1
2998-08-5
456
10810
no
no
Details
213-120-5
925-60-0
380
11980
no
no
Details
219-696-4
2499-59-4
448
11890
no
no
Details
205-480-7
141-32-2
325
10780
no
no
Details
212-454-9
818-61-1
371
11830
11510
no
no
Details
202-500-6
96-33-3
176
11710
no
no
Details
211-710-7
689-12-3
365
11680
no
no
Details
203-417-8
106-63-8
218
11590
no
no
Details
205-438-8
140-88-5
323
11470
no
no
Details
218-463-4
2156-97-0
437
11245
no
no
0.05 mg/kg
Details
235-697-2
12542-30-2
605
11005
no
no
0.05 mg/kg
Details
219-673-9
2495-35-4
446
10750
no
no
Details
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).
Details
203-080-7
103-11-7
206
11500
no
no
0.05 mg/kg
Details
201-177-9
79-10-7
147
10690
no
no
Details
201-173-7
79-06-1
145
10630
no
no
0.01 mg/kg
Details
500-148-0
61788-89-4
705
10599/91
10599/90A
no
no
Details
500-231-1
68783-41-5
733
10599/93
10599/92A
no
no
Details
200-816-9
74-86-2
126
10210
no
no
Details
203-545-4
108-05-4
231
10120
no
no
12 mg/kg
Details
200-836-8
75-07-0
128
10060
no
no
Details
208-178-3
514-10-3
346
10030
no
no
Details
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.
Details
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).
Details
240-759-7
16712-64-4
624
18897
no
no
0.05 mg/kg
Details
-
-
823
24889
no
no
5 mg/kg
Details
223-578-8
3965-55-7
471
24888
no
no
0.05 mg/kg
Details
240-347-7
16219-75-3
621
17110
no
no
0.05 mg/kg
Details
202-679-0
98-54-4
186
14020
no
no
0.05 mg/kg
Details
211-720-1
691-37-2
366
22150
no
no
0.05 mg/kg
Details
209-968-0
599-64-4
358
14841
no
no
0.05 mg/kg
Details
204-251-9
118-45-6
787
14628
no
no
0.05 mg/kg
SML expressed as 4-chlorophthalic acid.
Details
216-847-6
1679-51-2
427
18896
no
no
0.05 mg/kg
Details
431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
Details
402-130-7
106246-33-7
755
21765
no
no
0.05 mg/kg
Details
201-250-5
80-09-1
154
13617
16090
no
no
0.05 mg/kg
Details
202-200-5
92-88-6
170
16000
no
no
6 mg/kg
Details
206-466-3
345-92-6
337
15820
no
no
0.05 mg/kg
Details
201-247-9
80-07-9
152
15610
no
no
0.05 mg/kg
Details
201-248-4
80-08-0
153
15267
no
no
5 mg/kg
Details

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