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 28 March 2024. Database contains 1080 unique substances/entries.
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68
73160
yes
yes
0.05 mg/kg
Details
843-672-8
1227937-46-3
1076
yes
no
0.05 mg/kg
Only to be used (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.
Details
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-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
Details
-
-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
Details
201-898-9
89-32-7
166
24057
no
no
0.05 mg/kg
Details
248-104-7
26914-43-2
656
24760
no
no
0.05 mg/kg
Details
204-126-9
116-14-3
281
25120
no
no
0.05 mg/kg
Details
-
-
6
25380
no
no
0.05 mg/kg
Details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
Details
-
-
92
93970
yes
no
0.05 mg/kg
Details
-
-
924
94987
yes
no
0.05 mg/kg
Only for use in PET in contact with all types of foods other than fatty, high- alcoholic and dairy products.
Details
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
Details
201-081-7
78-08-0
142
26305
no
no
0.05 mg/kg
Only to be used as a surface treatment agent.
Details
220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
Details
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-
93
95858
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.
Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).
Details
641-029-4
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
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
Details
257-624-3
52047-59-3
692
52320
yes
yes
0.06 mg/kg
Details
201-557-4
84-74-2
157
74880
yes
no
0.12 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
442-650-1
37296-97-2
685
85950
yes
no
0.15 mg/kg
SML expressed as fluoride.
Only to be used in layers of multi-layer materials not coming into direct contact with food.
Details
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-
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
617-129-9
8062-15-5
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
223-805-0
4080-31-3
474
43600
yes
no
0.3 mg/kg
Details
202-525-2
96-69-5
178
92800
yes
yes
0.48 mg/kg
Details
-
-
178
92800
yes
yes
0.48 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
204-617-8
123-31-9
295
48620
15940
18867
yes
no
0.6 mg/kg
Details
230-426-4
7128-64-5
500
38560
yes
yes
0.6 mg/kg
Details
204-337-6
119-61-9
286
38240
yes
yes
0.6 mg/kg
Details
247-952-5
26741-53-7
652
38820
yes
yes
0.6 mg/kg
Details
614-830-1
68951-50-8
735
40120
yes
no
0.6 mg/kg
Details
204-211-0
117-81-7
283
74640
yes
no
0.6 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
Details
231-555-9
7632-00-0
506
86920
yes
no
0.6 mg/kg
Details
203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
Details
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-
23
43515
yes
no
0.9 mg/kg
Details
CG 27-145
411-220-5
134701-20-5
765
49485
yes
yes
1 mg/kg
Details
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-
765
49485
yes
yes
1 mg/kg
Details
700-485-5
939402-02-5
974
74050
yes
yes
1 mg/kg
The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.
Details
222-020-0
3319-31-1
1078
yes
no
1 mg/kg
Only to be used as plasticiser to manufacture soft poly(vinyl chloride).
Not to be used in contact with foods intended for infants.
Details
274-570-6
70321-86-7
738
60320
yes
yes
1.5 mg/kg
Details
256-318-7
47465-97-4
691
13600
no
no
1.8 mg/kg
Details
228-253-4
6200-40-4
493
39200
yes
no
1.8 mg/kg
Details
-
-
799
77708
yes
no
1.8 mg/kg
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
Details
423-560-1
161717-32-4
774
95270
yes
yes
2 mg/kg
SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP.
Details
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-
814
91815
yes
no
2 mg/kg
Details
203-585-2
108-46-3
237
24072
15910
no
no
2.4 mg/kg
Details
204-679-6
124-09-4
305
18460
15274
no
no
2.4 mg/kg
Details
-
61269-61-2
701
40160
yes
no
2.4 mg/kg
Details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
Details
255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
Details

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