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 28 September 2021. Database contains 1072 unique substances/entries.
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26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
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287916-86-3
871
yes
no
Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.
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37205-99-5
682
53270
yes
no
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5136-44-7
486
54005
yes
no
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-
34
54270
yes
no
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-
-
35
54280
yes
no
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-
36
54450
yes
no
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-
37
54480
yes
no
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-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
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29204-02-2
667
55190
yes
no
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-
38
55520
yes
no
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-
39
55600
yes
no
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99880-64-5
754
56020
yes
no
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26402-23-3
647
56720
yes
no
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-
54
57040
yes
no
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-
55
57120
yes
no
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-
56
57200
yes
no
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-
57
57280
yes
no
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-
58
57600
yes
no
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-
59
57680
yes
no
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-
44
56495
yes
no
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-
41
56486
yes
no
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-
42
56487
yes
no
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-
43
56490
yes
no
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-
45
56500
yes
no
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-
46
56510
yes
no
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-
48
56535
yes
no
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-
51
56570
yes
no
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-
60
58300
yes
no
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-
1060
yes
no
Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E.
The seed hulls shall be obtained from sunflower seeds that are fit for human consumption.
The processing temperature of the plastic containing the additive shall not exceed 240 °C.
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789
60027
yes
no
Average molecular weight not less than 440 Da.
Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).
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8001-39-6
525
62640
yes
no
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28290-79-1
663
64150
yes
no
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-
62
64500
yes
no
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12626-88-9
606
65200
yes
no
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-
63
65440
yes
no
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54276-35-6
694
21400
no
no
0.05 mg/kg
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-
818
21530
no
no
5 mg/kg
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37206-01-2
683
66200
yes
no
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9004-59-5
557
66640
yes
no
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-
64
66695
yes
no
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-
1062
no
no
Only to be used for the production of recycled PET and at up to 0,12 % (w/w).
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-
65
67155
yes
no
Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation).
Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %)
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-
66
67600
yes
no
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-
67
67840
yes
no
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-
1030
yes
no
0.05 mg/kg
Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below.
The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food.
Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
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-
1075
yes
no
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
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61269-61-2
701
40160
yes
no
2.4 mg/kg
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132459-54-2
764
13317
no
no
0.05 mg/kg
Purity > 98,1 % (w/w).
Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).
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153250-52-3
772
47500
yes
no
5 mg/kg
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