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 23 April 2024. Database contains 1080 unique substances/entries.
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215-175-0
1309-64-4
398
35760
yes
no
Details
215-171-9
1309-48-4
397
64720
yes
no
Details
215-170-3
1309-42-8
396
64640
yes
no
Details
215-138-9
1305-78-8
395
41520
yes
no
Details
215-137-3
1305-62-0
394
41280
yes
no
Details
A colloidal clay. Consists primarily of montmorillonite.
215-108-5
1302-78-9
393
37280
yes
no
Details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
Details
214-703-7
1187-93-5
391
22932
no
no
0.05 mg/kg
Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.
Details
214-620-6
1166-52-5
390
55200
yes
no
Details
214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
Details
214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
Details
214-068-6
1076-97-7
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
Details
213-853-0
1034-01-1
386
55280
yes
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
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
213-551-9
976-56-7
1007
no
no
Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
213-424-8
947-04-6
382
19490
no
no
5 mg/kg
Details
213-245-5
931-88-4
381
15030
no
no
0.05 mg/kg
Only to be used in polymers contacting foods for which simulant A is laid down.
Details
213-120-5
925-60-0
380
11980
no
no
Details
213-103-2
924-42-5
379
21940
no
no
0.01 mg/kg
Details
213-086-1
923-02-4
378
21970
no
no
0.05 mg/kg
Details
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.
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
212-782-2
868-77-9
374
21190
no
no
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
Details
212-485-8
822-06-0
372
18640
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
212-454-9
818-61-1
371
11830
11510
no
no
Details
212-084-8
760-93-0
370
21460
no
no
Details
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
211-750-5
693-36-7
368
93280
yes
yes
Details
211-746-3
693-23-2
367
16697
no
no
Details
211-720-1
691-37-2
366
22150
no
no
0.05 mg/kg
Details
211-710-7
689-12-3
365
11680
no
no
Details
211-492-3
652-67-5
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
211-471-9
646-25-3
863
15260
no
no
0.05 mg/kg
Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
211-128-3
630-08-0
362
14350
no
no
Details
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
210-826-5
624-03-3
1048
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
210-647-2
620-67-7
360
57920
yes
no
Details
210-478-4
616-38-6
1067
no
no
Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
Details
210-288-1
611-99-4
359
15970
48720
yes
no
Details
209-968-0
599-64-4
358
14841
no
no
0.05 mg/kg
Details
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.
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
209-548-7
585-07-9
355
20170
no
no
Details

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