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 16 June 2021. Database contains 1072 unique substances/entries.
Filter the list

 
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1043
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
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-
859
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
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-
998
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
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-
855
40560
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
Details
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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
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-
866
40620
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.
Details
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40471-03-2
867
40815
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.
Details
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-
1016
yes
no
Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA.
The final material shall be used at room temperature or below.
Details
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37953-21-2
857
66765
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
Details
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-
979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
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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
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227099-60-7
781
95265
yes
no
0.05 mg/kg
Details
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78301-43-6
742
92700
yes
yes
5 mg/kg
Details
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1547-26-8
1063
no
no
Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
Details
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3293-97-8
464
61280
yes
yes
Details
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37486-69-4
903
yes
no
Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.
Details
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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
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958445-44-8
896
71958
yes
no
Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.
Details
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26
46700
yes
no
5 mg/kg
Details
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823
24889
no
no
5 mg/kg
Details
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-
27
48960
yes
no
5 mg/kg
Details
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-
7
30370
yes
no
Details
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-
8
30401
yes
no
Details
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-
11
30960
yes
no
Details
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-
9
30610
yes
no
Details
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-
801
30607
yes
no
Details
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-
10
30612
yes
no
Details
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-
879
31336
yes
no
Details
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-
878
31335
yes
no
Details
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-
880
31348
yes
no
Details
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-
12
31328
yes
no
Details
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174254-23-0
777
31542
yes
no
0,5 % in final product.
Details
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266309-43-7
1
12310
no
no
Details
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266309-43-7
2
12340
no
no
Details
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-
3
12375
no
no
Details
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-
13
33120
yes
no
Details
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-
16
34230
yes
no
6 mg/kg
Details
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-
17
34281
yes
no
Details
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-
15
34130
yes
yes
30 mg/kg
Details
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-
752
39890
yes
no
Details
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-
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
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-
109
81840
23740
yes
no
Details
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-
343
23770
no
no
0.05 mg/kg
Details
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806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
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-
364
15404
no
no
5 mg/kg
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
Details
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361
18700
no
no
0.05 mg/kg
Details
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-
123
13840
no
no
Details
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-
267
15100
no
no
Details
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-
681
18310
no
no
Details
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-
331
22480
no
no
Details
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-
265
22600
no
no
Details
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-
124
22870
no
no
Details
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-
122
23800
no
no
Details
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-
443
12788
no
no
5 mg/kg
Details
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-
369
12761
no
no
0.05 mg/kg
Details
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-
214
61840
yes
no
Details
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-
285
66480
yes
yes
Details
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-
137
66580
yes
yes
Details
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-
472
66560
yes
yes
Details
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-
881
25187
no
no
5 mg/kg
Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
Details
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484
13395
no
no
0.05 mg/kg
Details
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-
882
25872
no
no
0.05 mg/kg
Details
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-
758
38940
yes
yes
Details
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-
756
40020
yes
yes
Details
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-
765
49485
yes
yes
1 mg/kg
Details
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-
477
46720
yes
yes
4.8 mg/kg
Details
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-
315
46640
yes
no
3 mg/kg
Details
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-
352
16360
no
no
0.05 mg/kg
Details
-
-
389
22360
no
no
5 mg/kg
Details
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-
770
51700
yes
no
0.05 mg/kg
Details
-
-
617
10660
no
no
0.05 mg/kg
Details
-
-
326
12763
35170
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
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-
209
17050
no
no
30 mg/kg
Details
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-
118
23830
81882
yes
no
Details
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-
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
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-
178
92800
yes
yes
0.48 mg/kg
Details
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-
358
14841
no
no
0.05 mg/kg
Details
-
-
186
14020
no
no
0.05 mg/kg
Details
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-
346
10030
no
no
Details
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-
115
10090
30000
yes
no
Details
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-
147
10690
no
no
Details
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-
303
31730
12130
yes
no
Details
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-
566
33350
yes
no
Details
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-
345
35840
yes
no
Details
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-
518
35845
yes
no
Details
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-
101
36000
yes
no
Details
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-
302
12820
no
no
Details
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-
272
37040
yes
no
Details
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-
116
13090
37600
yes
no
Details
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-
194
13150
no
no
Details
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-
766
38879
yes
no
Details
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-
743
38950
yes
no
Details
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-
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
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-
752
39890
yes
no
Details
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-
584
13620
40320
yes
no
Details
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-
229
14140
no
no
Details
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-
304
41960
14320
yes
no
Details
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-
139
14680
44160
yes
no
Details
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-
467
14800
45600
yes
no
Details
-
-
752
39890
yes
no
Details

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