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 13 April 2021. Database contains 122724 unique substances/entries.
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203-049-8
102-71-6
793
94000
yes
no
0.05 mg/kg
SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine.
Details
203-953-2
112-27-6
266
94320
25510
yes
no
Details
204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
Details
203-812-5
110-88-3
255
25900
no
no
5 mg/kg
Details
406-060-8
110638-71-6
757
95725
yes
no
Details
237-772-5
13983-17-0
613
95905
yes
no
Details
234-394-2
11138-66-2
596
95935
yes
no
Details
215-222-5
1314-13-2
402
96240
yes
no
Details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
Details
215-222-5
1314-13-2
1046
yes
no
Only to be used in unplasticised polymers.
The restrictions and specifications specified for FCM substance No 788 shall be respected.
Details
215-251-3
1314-98-3
403
96320
yes
no
Details
604-838-3
152261-33-1
803
33535
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Not to be used in contact with alcoholic foods.
Details
233-007-4
10016-20-3
580
46070
yes
no
Details
-
156065-00-8
874
16265
no
no
0.05 mg/kg
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
-
156065-00-8
874
16265
no
no
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
204-872-5
127-91-3
314
23500
no
no
Details
-
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
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
608-050-0
27136-15-8
869
66763
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.
Details
405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
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
245-217-3
22788-19-8
630
82240
yes
no
Details
248-315-4
27194-74-7
659
82800
yes
no
Details
249-369-1
29013-28-3
665
83120
yes
no
Details
248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
Details
-
227099-60-7
781
95265
yes
no
0.05 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
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
Details
412-440-4
2725-22-6
452
38885
yes
no
5 mg/kg
Details
247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
219-470-5
2440-22-4
444
61440
yes
no
Details
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
220-239-6
2682-20-4
451
66755
yes
no
0.5 mg/kg
Only to be used in aqueous polymer dispersions and emulsions.
Details
-
203255-81-6
792
92475
yes
yes
5 mg/kg
SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products.
Details
245-818-0
23676-09-7
632
52880
yes
no
3.6 mg/kg
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
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
-
25134-51-4
636
31500
yes
no
Details
-
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
Details
219-673-9
2495-35-4
446
10750
no
no
Details
218-463-4
2156-97-0
437
11245
no
no
0.05 mg/kg
Details
219-696-4
2499-59-4
448
11890
no
no
Details
221-072-1
2998-08-5
456
10810
no
no
Details
218-001-1
2035-75-8
432
12280
no
no
Details
-
266309-43-7
2
12340
no
no
Details
-
266309-43-7
1
12310
no
no
Details
244-492-7
21645-51-2
629
34560
yes
no
Details

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