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 04 July 2022. Database contains 1072 unique substances/entries.
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201-557-4
84-74-2
157
74880
yes
no
0.3 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
223-805-0
4080-31-3
474
43600
yes
no
0.3 mg/kg
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
-
-
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
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
257-624-3
52047-59-3
692
52320
yes
yes
0.06 mg/kg
Details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
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
-
-
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
220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
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
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
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
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
-
-
92
93970
yes
no
0.05 mg/kg
Details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
Details
-
-
6
25380
no
no
0.05 mg/kg
Details
204-126-9
116-14-3
281
25120
no
no
0.05 mg/kg
Details
248-104-7
26914-43-2
656
24760
no
no
0.05 mg/kg
Details
201-898-9
89-32-7
166
24057
no
no
0.05 mg/kg
Details
-
-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
Details
-
-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
Details
843-672-8
1227937-46-3
1076
yes
no
0.05 mg/kg
Only to be used as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended 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.
Details
-
-
68
73160
yes
yes
0.05 mg/kg
Details
216-600-2
1623-05-8
423
22937
no
no
0.05 mg/kg
Details
214-703-7
1187-93-5
391
22932
no
no
0.05 mg/kg
Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.
Details
429-160-3
178671-58-4
778
71670
yes
yes
0.05 mg/kg
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
248-093-9
26896-20-8
819
68110
yes
no
0.05 mg/kg
Not to be used in polymers contacting fatty foods.
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
SML expressed as neodecanoic acid.
Details
225-218-5
4724-48-5
483
68860
yes
no
0.05 mg/kg
Details
213-086-1
923-02-4
378
21970
no
no
0.05 mg/kg
Details
271-487-7
68564-88-5
731
18220
no
no
0.05 mg/kg
Details
203-157-5
103-90-2
208
18898
no
no
0.05 mg/kg
Details
203-867-5
111-41-1
262
35284
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.
For indirect food contact only, behind a PET layer.
Details
282-811-1
84434-12-8
748
12765
no
no
0.05 mg/kg
Details
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
237-457-2
13811-50-2
612
16694
no
no
0.05 mg/kg
Details
-
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).
Details
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
795
40155
yes
no
0.05 mg/kg
Details
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
791
92470
yes
no
0.05 mg/kg
Details
-
-
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.
Details
247-063-2
25513-64-8
641
22331
no
no
0.05 mg/kg
Details
-
54276-35-6
694
21400
no
no
0.05 mg/kg
Details
202-617-2
97-90-5
185
20440
no
no
0.05 mg/kg
Details
218-218-1
2082-81-7
434
20410
no
no
0.05 mg/kg
Details
202-943-5
101-43-9
197
20260
no
no
0.05 mg/kg
Details
202-473-0
96-05-9
175
20050
no
no
0.05 mg/kg
Details
215-951-9
1459-93-4
420
19210
no
no
0.05 mg/kg
Details
203-678-8
109-53-5
243
19060
no
no
0.05 mg/kg
Details
607-708-4
25359-91-5
640
54930
yes
no
0.05 mg/kg
Details

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