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 02 March 2021. Database contains 1072 unique substances/entries.
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410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
618-128-6
882073-43-0
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
-
-
816
45704
yes
no
5 mg/kg
Details
-
-
817
38507
yes
no
5 mg/kg
Not to be used with polyethylene in contact with acidic foods.
Purity ≥ 96 %.
Details
203-865-4
111-40-0
261
15790
no
no
5 mg/kg
Details
221-800-8
3238-40-2
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
213-424-8
947-04-6
382
19490
no
no
5 mg/kg
Details
-
-
818
21530
no
no
5 mg/kg
Details
288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
Details
481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
Details
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
Details
-
153250-52-3
772
47500
yes
no
5 mg/kg
Details
204-393-1
120-40-1
923
39150
yes
no
5 mg/kg
The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, shall not result in a migration of diethanolamine higher than 0,3 mg/kg food.
Details
-
-
810
68119
yes
no
5 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
233-226-5
10094-45-8
587
68400
yes
yes
5 mg/kg
Details
240-367-6
16260-09-6
622
69840
yes
yes
5 mg/kg
Details
271-867-2
68610-51-5
732
45450
yes
yes
5 mg/kg
Details
416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
Details
-
90751-07-8
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
Details
606-265-4
192268-64-7
780
81220
yes
no
5 mg/kg
Details
-
-
78
77897
yes
no
5 mg/kg
Details
618-558-4
9046-01-9
578
79600
yes
no
5 mg/kg
For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
Details
-
-
813
91530
yes
no
5 mg/kg
Details
204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
Details
-
-
815
94985
yes
no
5 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
203-812-5
110-88-3
255
25900
no
no
5 mg/kg
Details
200-867-7
75-38-7
132
26140
no
no
5 mg/kg
Details
201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
Details
204-427-5
120-80-9
289
24051
15880
no
no
6 mg/kg
Details
254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
Details
252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
688-151-4
118337-09-0
759
54300
yes
yes
6 mg/kg
Details
265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
Details
235-841-4
13003-12-8
608
40800
yes
yes
6 mg/kg
Details
202-200-5
92-88-6
170
16000
no
no
6 mg/kg
Details
262-634-6
61167-58-6
700
31520
yes
yes
6 mg/kg
Details
-
-
16
34230
yes
no
6 mg/kg
Details
-
-
333
69920
22775
yes
no
6 mg/kg
Details
200-871-9
75-45-6
134
43680
yes
no
6 mg/kg
Content of chlorofluoromethane less than 1 mg/kg of the substance.
Details
251-073-2
32509-66-3
673
53670
yes
yes
6 mg/kg
Details
200-311-3
57-09-0
104
58960
yes
no
6 mg/kg
Details
218-216-0
2082-79-3
433
68320
yes
yes
6 mg/kg
Details
205-634-3
144-62-7
333
22775
69920
yes
no
6 mg/kg
Details
-
-
71
76730
yes
no
6 mg/kg
Details
-
120218-34-0
761
92930
yes
no
6 mg/kg
Details
-
-
88
86880
yes
no
9 mg/kg
Details
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
Details
700-485-5
939402-02-5
974
74050
yes
yes
10 mg/kg
SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.
Details

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