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 11 June 2021. Database contains 1072 unique substances/entries.
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927-697-2
28931-67-1
664
95000
yes
no
Details
923-642-1
106392-12-5
551
79920
yes
no
Details
915-277-1
32052-51-0
4
22332
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
843-672-8
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
813-638-7
80512-44-3
1061
no
no
Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.
Details
811-989-0
12072-90-1
600
60030
yes
no
Details
700-485-5
939402-02-5
974
74050
yes
yes
10 mg/kg
SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.
Details
700-485-5
939402-02-5
974
74050
yes
yes
1 mg/kg
The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.
Details
700-323-3
908020-52-0
926
71955
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
Details
700-107-9
87189-25-1
751
81515
yes
no
Details
695-178-5
9044-17-1
577
62280
yes
no
Details
688-151-4
118337-09-0
759
54300
yes
yes
6 mg/kg
Details
686-629-7
68412-29-3
723
88880
yes
no
Details
682-678-3
182121-12-6
779
39815
yes
yes
0.05 mg/kg
Details
682-238-0
1190931-27-1
1045
yes
no
Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.
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
681-637-7
25134-51-4
636
31500
yes
no
Details
681-637-7
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
Details
680-864-9
12198-93-5
602
70240
yes
no
Details
680-598-3
70142-34-6
737
77370
yes
no
Details
680-272-0
51798-33-5
860
71980
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.
Details
641-029-4
156065-00-8
874
16265
no
no
0.05 mg/kg
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
641-029-4
156065-00-8
874
16265
no
no
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
630-556-5
124578-12-7
812
80350
yes
no
Only to be used in plastics up to 0,1 % w/w.
Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.
Details
626-593-1
4128-73-8
476
16570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
618-565-2
9049-76-7
579
61800
yes
no
Details
618-558-4
9046-01-9
578
79600
yes
no
5 mg/kg
For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
Details
618-528-0
9032-42-2
576
60880
yes
no
Details
618-459-6
9010-88-2
868
53245
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
618-424-5
9005-71-4
573
79440
yes
no
Details
618-422-4
9005-70-3
572
79360
yes
no
Details
618-421-9
9005-66-7
570
79200
yes
no
Details
618-414-0
9005-37-2
567
82080
yes
no
Details
618-410-9
9005-27-0
565
61120
yes
no
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
618-392-2
9004-70-0
562
22450
no
no
Details
618-391-7
9004-67-5
561
66240
yes
no
Details
618-389-6
9004-65-3
560
66700
yes
no
Details
618-388-0
9004-64-2
559
61680
yes
no
Details
618-387-5
9004-62-0
558
60560
yes
no
Details
618-385-4
9004-58-4
556
54260
yes
no
Details
618-384-9
9004-57-3
555
53280
yes
no
Details
618-381-2
9004-36-8
554
43300
yes
no
Details
618-363-4
9003-39-8
552
81500
yes
no
The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC [OJ L 253, 20.9.2008, p. 1.].
Details
618-355-0
9003-11-6
551
79920
yes
no
Details
618-352-4
9003-07-0
550
81060
yes
no
Details
618-339-3
9002-88-4
549
80000
yes
no
Details
618-326-2
9000-11-7
542
42640
yes
no
Details
618-128-6
882073-43-0
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details
617-335-9
82451-48-7
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
617-241-8
81541-12-0
752
39890
yes
no
Details
617-129-9
8062-15-5
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
616-996-0
80181-31-3
744
18888
no
no
The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.
Details
616-108-1
745070-61-5
784
95420
yes
no
5 mg/kg
Details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
Details
614-830-1
68951-50-8
735
40120
yes
no
0.6 mg/kg
Details
614-610-5
68554-70-1
730
66930
yes
no
Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
613-156-5
63148-62-9
575
76721
yes
no
Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
611-185-8
54686-97-4
752
39890
yes
no
Details
609-415-7
37353-59-6
686
61390
yes
no
Details
609-389-7
37293-22-4
598
41600
yes
no
Details
609-369-8
37244-96-5
684
68125
yes
no
Details
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).
Details
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).
Details
608-428-5
29894-35-7
668
80240
yes
no
Details
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 %.
Details
607-789-6
25736-61-2
642
64990
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,05 % (w/w).
Details
607-759-2
25618-55-7
1017
yes
no
To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
Details
607-708-4
25359-91-5
640
54930
yes
no
0.05 mg/kg
Details
607-698-1
25322-99-0
865
40619
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.
Details
607-457-0
24937-78-8
969
yes
no
Only to be used as a polymeric additive up to 2 % w/w in polyolefins.
The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
Details
606-340-1
19569-21-2
627
59760
yes
no
Details
606-265-4
192268-64-7
780
81220
yes
no
5 mg/kg
Details
604-838-3
152261-33-1
803
33535
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Not to be used in contact with alcoholic foods.
Details
604-520-4
146340-15-0
802
33105
yes
no
5 mg/kg
Details
602-916-1
12304-65-3
604
60080
yes
no
Details
602-803-7
12269-78-2
603
83460
yes
no
Details
601-648-2
12001-26-2
597
67120
yes
no
Details
500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
Details
500-231-1
68783-41-5
733
10599/92A
10599/93
no
no
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
500-148-0
61788-89-4
705
10599/90A
10599/91
no
no
Details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
Details
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
Details
1 - 4.5 moles propoxylated
500-039-8
25322-69-4
639
80800
23651
yes
no
Details
1 - 4.5 moles ethoxylated
500-038-2
25322-68-3
638
23590
76960
yes
no
Details
1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
Details
1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
Details
1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
Details
485-230-3
1455-42-1
1052
no
no
5 mg/kg
Only to be used as a monomer in the production of polyesters.
The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).
Details
481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
Details
455-890-7
6607-41-6
872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
Details
451-530-8
736150-63-3
783
55910
yes
no
Details
438-600-3
110675-26-8
758
38940
yes
yes
Details

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