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 26 February 2021. Database contains 1072 unique substances/entries.
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20
39120
yes
no
SML(T) expressed excluding HCl.
Details
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852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
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14
33801
yes
no
30 mg/kg
Details
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66822-60-4
719
65920
yes
no
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.
Details
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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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12198-93-5
602
70240
yes
no
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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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
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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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147398-31-0
1059
no
no
Only to be used either alone or blended with other polymers in contact with all foods under contact conditions of up to 6 months and/or 6 months and more, at room temperature or below, including hot fill or a short heating up phase.
The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food.
Details
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1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
Details
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90751-07-8
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
Details
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70
76463
yes
no
Details
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661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
Details
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167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
Details
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71
76730
yes
no
6 mg/kg
Details
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73018-26-5
797
76807
yes
yes
Details
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73018-26-5
797
76807
yes
yes
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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13445-56-2
609
83455
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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68412-29-3
723
88880
yes
no
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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