plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorized Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation (EU) 2023/1627, OJ L 201, 11 August 2023

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 19 April 2024. Database contains 1080 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
919-828-7
308066-94-6
39
55600
yes
no
Details
915-277-1
32052-51-0
4
22332
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
882-488-2
12626-88-9
606
65200
yes
no
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 (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for 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; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.
Details
843-371-1
25101-28-4
856
40563
yes
no
Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
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
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
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
Details
681-637-7
25134-51-4
636
31500
yes
no
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
623-712-9
14797-73-0
822
71938
yes
no
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

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