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 April 2021. Database contains 122724 unique substances/entries.
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818
21530
no
no
5 mg/kg
Details
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64
66695
yes
no
Details
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1062
no
no
Only to be used for the production of recycled PET and at up to 0,12 % (w/w).
Details
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65
67155
yes
no
Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation).
Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %)
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66
67600
yes
no
Details
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67
67840
yes
no
Details
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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
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1075
yes
no
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
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19
39090
yes
no
Details
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20
39120
yes
no
SML(T) expressed excluding HCl.
Details
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14
33801
yes
no
30 mg/kg
Details
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810
68119
yes
no
5 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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810
68119
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
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822
71938
yes
no
0.002 mg/kg
Details
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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.
Details
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68
73160
yes
yes
0.05 mg/kg
Details
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69
74400
yes
yes
30 mg/kg
Details
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728
75100
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
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728
75100
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
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729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
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729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
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820
76420
yes
no
Details
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70
76463
yes
no
Details
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71
76730
yes
no
6 mg/kg
Details
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72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
Details
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73
76866
yes
yes
Details
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73
76866
yes
yes
Details
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76
77732
yes
no
0.05 mg/kg
Only for use in PET.
Details
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77
77733
yes
no
0.05 mg/kg
Only for use in PET.
Details
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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
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78
77897
yes
no
5 mg/kg
Details
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74
77440
yes
yes
42 mg/kg
Details
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75
77702
yes
no
Details
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79
80640
yes
no
Details
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80
81760
yes
no
Details
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81
83320
yes
no
Details
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82
83325
yes
no
Details
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83
83330
yes
no
Details
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84
85601
yes
no
Details
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85
85610
yes
no
Details
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86
86000
yes
no
Details
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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.
Details
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88
86880
yes
no
9 mg/kg
Details
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89
89440
yes
no
Details
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821
90810
yes
no
Details
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813
91530
yes
no
5 mg/kg
Details
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814
91815
yes
no
2 mg/kg
Details
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90
92195
yes
no
Details
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91
92320
yes
yes
15 mg/kg
Details
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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.
Details

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