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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221-698-5
3195-78-6
462
26170
no
no
0.02 mg/kg
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608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
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608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
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221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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221-639-3
3173-53-3
460
14950
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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250-709-6
31570-04-4
671
74240
yes
no
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221-532-1
3135-18-0
459
46870
yes
no
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250-379-3
30899-62-8
670
56800
yes
no
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221-304-1
3061-75-4
458
36960
yes
no
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250-097-0
30233-64-8
669
56610
yes
no
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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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206-103-9
301-02-0
335
68960
yes
no
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221-073-7
2998-18-7
457
20140
no
no
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221-072-1
2998-08-5
456
10810
no
no
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608-428-5
29894-35-7
668
80240
yes
no
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-
29204-02-2
667
55190
yes
no
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249-448-0
29116-98-1
666
87280
yes
no
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249-369-1
29013-28-3
665
83120
yes
no
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927-697-2
28931-67-1
664
95000
yes
no
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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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220-688-8
2867-47-2
455
20530
no
no
0.01 mg/kg
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249-079-5
28553-12-0
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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249-079-5
28553-12-0
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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220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
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-
28290-79-1
663
64150
yes
no
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405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
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220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
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248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
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248-468-7
27458-90-8
660
47540
yes
yes
0.05 mg/kg
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412-440-4
2725-22-6
452
38885
yes
no
5 mg/kg
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248-315-4
27194-74-7
659
82800
yes
no
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248-289-4
27176-87-0
658
52000
yes
no
30 mg/kg
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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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248-227-6
27107-89-7
657
67680
yes
no
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248-104-7
26914-43-2
656
24760
no
no
0.05 mg/kg
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248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
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248-093-9
26896-20-8
819
68110
yes
no
0.05 mg/kg
Not to be used in polymers contacting fatty foods.
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
SML expressed as neodecanoic acid.
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248-027-9
26836-47-5
654
88600
yes
no
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220-239-6
2682-20-4
451
66755
yes
no
0.5 mg/kg
Only to be used in aqueous polymer dispersions and emulsions.
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247-977-1
26761-40-0
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.
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247-977-1
26761-40-0
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.
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247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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247-952-5
26741-53-7
652
38820
yes
yes
0.6 mg/kg
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247-891-4
26658-19-5
651
88240
yes
no
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247-862-6
26636-01-1
650
49600
yes
no
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-
266309-43-7
2
12340
no
no
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-
266309-43-7
1
12310
no
no
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-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
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247-668-1
26402-26-6
648
56880
yes
no
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-
26402-23-3
647
56720
yes
no
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