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 30 April 2024. Database contains 1080 unique substances/entries.
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247-891-4
26658-19-5
651
88240
yes
no
Details
247-862-6
26636-01-1
650
49600
yes
no
Details
-
266309-43-7
1
12310
no
no
Details
-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
247-668-1
26402-26-6
648
56880
yes
no
Details
-
26402-23-3
647
56720
yes
no
Details
247-666-0
26401-97-8
646
50480
yes
no
Details
247-665-5
26401-86-5
645
67760
yes
no
Details
-
263244-54-8
885
45676
yes
no
Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.
Details
247-569-3
26266-58-0
644
88080
yes
no
Details
247-568-8
26266-57-9
643
87760
yes
no
Details
607-789-6
25736-61-2
642
64990
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,05 % (w/w).
Details
607-759-2
25618-55-7
1017
yes
no
To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
Details
219-882-5
2561-88-8
450
24430
no
no
Details
247-117-5
25583-20-4
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
247-063-2
25513-64-8
641
22331
no
no
0.05 mg/kg
Details
607-708-4
25359-91-5
640
54930
yes
no
0.05 mg/kg
Details
607-698-1
25322-99-0
865
40619
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.
Details
1 - 4.5 moles propoxylated
500-039-8
25322-69-4
639
23651
80800
yes
no
Details
1 - 4.5 moles ethoxylated
500-038-2
25322-68-3
638
23590
76960
yes
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
246-770-3
25265-71-8
257
16660
13550
51760
yes
no
Details
246-665-2
25151-96-6
637
71635
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.
Details
681-637-7
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
Details
681-637-7
25134-51-4
636
31500
yes
no
Details
843-371-1
25101-28-4
856
40563
yes
no
Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
Details
246-563-8
25013-16-5
635
40720
yes
no
30 mg/kg
Details
219-702-5
2500-88-1
449
49840
yes
yes
0.05 mg/kg
Details
219-696-4
2499-59-4
448
11890
no
no
Details
219-674-4
2495-37-6
447
20080
no
no
Details
219-673-9
2495-35-4
446
10750
no
no
Details
429-840-1
24937-78-8
969
yes
no
Only to be used as a polymeric additive up to 2 % w/w in polyolefins.
The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
Details
246-466-0
24800-44-0
634
25910
no
no
Details
219-574-0
2466-09-3
445
83440
yes
no
Details
219-547-3
2459-10-1
971
25885
no
no
Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.
Details
219-470-5
2440-22-4
444
61440
yes
no
Details
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
219-371-7
2425-79-8
442
13780
no
no
0.01 mg/kg
Residual content = 1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
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
219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
Details
-
23985-75-3
1066
no
no
0.05 mg/kg
Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III.
The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).
Details
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
245-818-0
23676-09-7
632
52880
yes
no
3.6 mg/kg
Details
219-020-8
2315-68-6
441
38160
yes
no
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
245-217-3
22788-19-8
630
82240
yes
no
Details
-
227099-60-7
781
95265
yes
no
0.05 mg/kg
Details
218-639-0
2210-28-8
440
21340
no
no
Details
218-542-3
2177-70-0
439
21280
no
no
Details

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