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 22 October 2021. Database contains 1072 unique substances/entries.
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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.
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200-018-0
50-21-5
99
19460
62960
yes
no
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-
99
19460
62960
yes
no
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222-852-4
3634-83-1
988
no
no
SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine.
To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.
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Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
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98
17260
54880
yes
no
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-
979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
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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.
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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.
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243-053-7
19430-93-4
973
22931
no
no
Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.
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235-285-2
12158-74-6
972
45197
yes
no
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219-547-3
2459-10-1
971
25885
no
no
Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.
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97
72081/10
yes
no
Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.
Properties: Viscosity at 120 °C: > 3 Pa.s,Softening point: > 95 °C as determined by ASTM Method E 28-67,Bromine number: < 40 (ASTM D1159),The colour of a 50 % solution in toluene < 11 on the Gardner scale,Residual aromatic monomer ≤ 50 ppm.
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607-457-0
24937-78-8
969
yes
no
Only to be used as a polymeric additive up to 2 % w/w in polyolefins.
The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
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96
95920
yes
no
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95
95883
yes
no
Average molecular weight not less than 480 Da.
Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
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94
95859
yes
no
Average molecular weight not less than 500 Da.
Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
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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).
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700-323-3
908020-52-0
926
71955
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
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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.
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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.
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92
93970
yes
no
0.05 mg/kg
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91
92320
yes
yes
15 mg/kg
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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.
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204-886-1
128-44-9
902
yes
no
The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (OJ L 83, 22.3.2012, p. 1).
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90
92195
yes
no
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9
30610
yes
no
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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.
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ANOX 1315; ANOX BF; DURAD AX 38
413-750-2
171090-93-0
895
47060
yes
no
0.05 mg/kg
Only to be used in polyolefins in contact with foods other than fatty/ high-alcoholic and dairy products.
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240-613-2
16545-54-3
894
93360
yes
no
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-
89
89440
yes
no
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263244-54-8
885
45676
yes
no
Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.
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293-728-5
91082-17-6
884
34240
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.
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224-709-1
4457-71-0
883
22074
no
no
0.05 mg/kg
Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg.
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882
25872
no
no
0.05 mg/kg
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219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
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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.
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221-140-0
3010-96-6
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.
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880
31348
yes
no
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-
88
86880
yes
no
9 mg/kg
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-
879
31336
yes
no
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-
878
31335
yes
no
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500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
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641-029-4
156065-00-8
874
16265
no
no
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).
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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).
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873
93460
yes
no
Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
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455-890-7
6607-41-6
872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
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287916-86-3
871
yes
no
Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.
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481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
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-
87
86285
yes
no
For synthetic amorphous silicon dioxide, silanated: primary particles of 1-100 nm which are aggregated to a size of 0,1-1 µm and may form agglomerates within the size distribution of 0,3 µm to the mm size.
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608-050-0
27136-15-8
869
66763
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.
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