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 20 January 2022. Database contains 1072 unique substances/entries.
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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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757
95725
yes
no
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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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593
44960
yes
no
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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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571
79280
yes
no
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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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569
79120
yes
no
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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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572
79360
yes
no
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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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540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
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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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564
24540
88800
yes
no
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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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535
24100
24190
83840
24130
yes
no
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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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872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
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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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706
17230
no
no
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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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807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
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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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257
16660
13550
51760
yes
no
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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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775
45705
yes
no
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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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734
46380
yes
no
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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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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.
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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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516
86960
yes
no
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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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768
34850
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.
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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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607
62245
yes
no
Only to be used in PET polymers and copolymers
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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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639
23651
80800
yes
no
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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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713
43480
yes
no
Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).
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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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705
10599/91
10599/90A
no
no
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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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551
79920
yes
no
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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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704
77600
yes
no
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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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529
67850
yes
no
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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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672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
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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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672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
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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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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.
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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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685
85950
yes
no
0.15 mg/kg
SML expressed as fluoride.
Only to be used in layers of multi-layer materials not coming into direct contact with food.
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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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411
42080
yes
no
Primary particles of 10 - 300 nm which are aggregated to a size of 100 - 1200 nm which may form agglomerates within the size distribution of 300 nm - mm.
Toluene extractables: maximum 0,1 %, determined according to ISO method 6209.
UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis.
Benzo(a)pyrene content: max 0,25 mg/kg carbon black.
Maximum use level of carbon black in the polymer: 2,5 % w/w.
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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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409
62240
yes
no
view-details
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
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502
22778
no
no
0.05 mg/kg
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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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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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Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
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811
80077
yes
no
60 mg/kg
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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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623
52640
yes
no
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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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546
71440
yes
no
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24
45280
yes
no
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25
45440
yes
no
12 mg/kg
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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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69226-46-6
30
50560
yes
no
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28
50160
yes
no
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31
50800
yes
no
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32
50880
yes
no
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33
51120
yes
no
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26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
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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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37205-99-5
682
53270
yes
no
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5136-44-7
486
54005
yes
no
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34
54270
yes
no
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35
54280
yes
no
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36
54450
yes
no
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