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 14 May 2021. Database contains 1072 unique substances/entries.
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247-117-5
25583-20-4
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.
Details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
Details
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.
Details
927-697-2
28931-67-1
664
95000
yes
no
Details
246-466-0
24800-44-0
634
25910
no
no
Details
220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
Details
243-814-3
20427-58-1
628
96190
yes
no
Details
-
37953-21-2
857
66765
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
Details
221-950-4
3290-92-4
463
25840
no
no
0.05 mg/kg
Details
252-816-3
35958-30-6
679
39060
yes
yes
5 mg/kg
Details
251-581-4
33587-20-1
677
82560
yes
no
Details
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.
Details
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
Details
223-054-9
3710-30-3
1034
no
no
0.05 mg/kg
Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.
Details
253-149-0
36653-82-4
681
18310
no
no
Details
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.
Details
253-781-7
38103-06-9
687
13614
13530
no
no
0.05 mg/kg
Details
223-445-4
3896-11-5
470
60400
yes
yes
Details
223-383-8
3864-99-1
469
60480
yes
yes
Details
-
3293-97-8
464
61280
yes
yes
Details
-
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.
Details
221-532-1
3135-18-0
459
46870
yes
no
Details
206-466-3
345-92-6
337
15820
no
no
0.05 mg/kg
Details
223-578-8
3965-55-7
471
24888
no
no
0.05 mg/kg
Details
222-067-7
3333-62-8
465
68040
yes
no
Details
609-389-7
37293-22-4
598
41600
yes
no
Details
221-304-1
3061-75-4
458
36960
yes
no
Details
223-077-4
3724-65-0
467
14800
45600
yes
no
Details
221-639-3
3173-53-3
460
14950
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
251-576-7
33568-99-9
676
50400
yes
no
Details
222-883-3
3648-18-8
466
50640
yes
no
Details
251-136-4
32647-67-9
674
46480
yes
no
Details
-
37205-99-5
682
53270
yes
no
Details
251-073-2
32509-66-3
673
53670
yes
yes
6 mg/kg
Details
221-800-8
3238-40-2
1031
no
no
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.
The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).
Details
250-097-0
30233-64-8
669
56610
yes
no
Details
250-379-3
30899-62-8
670
56800
yes
no
Details
253-407-2
37220-82-9
49
56540
yes
no
Details
609-415-7
37353-59-6
686
61390
yes
no
Details
-
37206-01-2
683
66200
yes
no
Details
915-277-1
32052-51-0
4
22332
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
251-156-3
32687-78-8
675
38800
yes
yes
15 mg/kg
Details
206-376-4
334-48-5
336
45940
15095
yes
no
Details
221-698-5
3195-78-6
462
26170
no
no
0.02 mg/kg
Details
609-369-8
37244-96-5
684
68125
yes
no
Details
206-103-9
301-02-0
335
68960
yes
no
Details
206-765-9
373-49-9
338
71020
yes
no
Details
682-234-9
329238-24-6
854
71943
yes
no
Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles.
Details
223-320-4
3825-26-1
468
71960
yes
no
Only to be used in repeated use articles, sintered at high temperatures.
Details

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