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 14 April 2021. Database contains 122724 unique substances/entries.
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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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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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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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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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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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-
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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