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 16 April 2024. Database contains 1080 unique substances/entries.
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229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
Details
228-250-8
6197-30-4
492
45650
yes
no
0.05 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
200-661-7
67-63-0
118
81882
23830
yes
no
Details
229-962-1
6864-37-5
498
16210
no
no
0.05 mg/kg
Only to be used in polyamides.
Details
267-342-2
67845-93-6
721
46800
yes
no
Details
265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
Details
210-288-1
611-99-4
359
15970
48720
yes
no
Details
211-720-1
691-37-2
366
22150
no
no
0.05 mg/kg
Details
229-662-0
6642-31-5
495
35160
yes
no
5 mg/kg
Details
200-580-7
64-19-7
115
30000
10090
yes
no
Details
200-662-2
67-64-1
119
30295
yes
no
Details
500-231-1
68783-41-5
733
10599/93
10599/92A
no
no
Details
500-148-0
61788-89-4
705
10599/91
10599/90A
no
no
Details
262-634-6
61167-58-6
700
31520
yes
yes
6 mg/kg
Details
211-710-7
689-12-3
365
11680
no
no
Details
200-618-2
65-85-0
116
37600
13090
yes
no
Details
264-122-8
63397-60-4
710
38700
yes
yes
18 mg/kg
Details
228-253-4
6200-40-4
493
39200
yes
no
1.8 mg/kg
Details
-
69158-41-4
752
39890
yes
no
Details
614-830-1
68951-50-8
735
40120
yes
no
0.6 mg/kg
Details
211-128-3
630-08-0
362
14350
no
no
Details
264-705-7
64147-40-6
712
42960
yes
no
Details
The product obtained by treating cellulose with caustic soda, reacting this with carbon disulfide, dissolving this in a dilute alkali solution and extruding into an acid to form a continuous viscose tube.
270-493-7
68442-85-3
727
43360
yes
no
Details
264-846-4
64365-11-3
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).
Details
-
69226-46-6
30
50560
yes
no
Details
268-500-3
68109-88-6
29
50360
yes
no
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
272-489-0
68855-54-9
734
46380
yes
no
Details
210-478-4
616-38-6
1067
no
no
Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
Details
200-664-3
67-68-5
120
49540
yes
no
Details
200-578-6
64-17-5
113
52800
16780
yes
no
Details
210-826-5
624-03-3
1048
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
200-449-4
60-00-4
111
53600
yes
no
Details
262-978-7
61788-47-4
703
17170
no
no
Details
269-657-0
68308-53-2
722
17200
no
no
Details
263-107-3
61790-12-3
706
17230
no
no
Details
200-579-1
64-18-6
114
55040
yes
no
Details
210-647-2
620-67-7
360
57920
yes
no
Details
228-601-5
6303-21-5
494
62140
yes
no
Details
200-470-9
60-33-3
112
64015
yes
no
Details
230-022-8
6915-15-7
499
19965
65020
yes
no
In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.
Details
200-659-6
67-56-1
117
21550
no
no
Details
614-610-5
68554-70-1
730
66930
yes
no
Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.
Details
266-836-5
67649-65-4
720
67360
yes
no
Details
-
61269-61-2
701
40160
yes
no
2.4 mg/kg
Details
211-746-3
693-23-2
367
16697
no
no
Details
271-487-7
68564-88-5
731
18220
no
no
0.05 mg/kg
Details
-
66822-60-4
719
65920
yes
no
Details
271-867-2
68610-51-5
732
45450
yes
yes
5 mg/kg
Details
229-722-6
6683-19-8
496
71680
yes
no
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
-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
Details
270-476-4
68442-12-6
726
83599
yes
yes
Details
266-041-3
65997-06-0
717
84210
yes
no
Details
266-042-9
65997-13-9
718
84240
yes
no
Details
264-848-5
64365-17-9
714
84400
yes
no
Details
263-600-3
62568-11-0
709
87520
yes
no
Details
262-958-8
61752-68-9
702
87920
yes
no
Details
686-629-7
68412-29-3
723
88880
yes
no
Details
270-337-8
68425-17-2
724
24903
no
no
In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].
Details
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
Details
229-176-9
6422-86-2
798
92200
yes
no
Details
211-750-5
693-36-7
368
93280
yes
yes
Details
201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
Details
200-866-1
75-37-6
131
48460
yes
no
Details
456-830-2
745070-61-5
784
95420
yes
no
5 mg/kg
Details
200-751-6
71-36-3
123
13840
no
no
Details
200-752-1
71-41-0
124
22870
no
no
Details
200-746-9
71-23-8
122
23800
no
no
Details
201-044-5
77-62-3
137
66580
yes
yes
Details
274-572-7
70331-94-1
739
70000
yes
no
Details
-
78301-43-6
742
92700
yes
yes
5 mg/kg
Details
230-426-4
7128-64-5
500
38560
yes
yes
0.6 mg/kg
Details
274-570-6
70321-86-7
738
60320
yes
yes
1.5 mg/kg
Details
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
Details
200-836-8
75-07-0
128
10060
no
no
Details
200-816-9
74-86-2
126
10210
no
no
Details
201-173-7
79-06-1
145
10630
no
no
0.01 mg/kg
Details
201-177-9
79-10-7
147
10690
no
no
Details
231-635-3
7664-41-7
510
12789
35320
yes
no
Details
-
7771-44-0
518
35845
yes
no
Details
NC-4
406-176-9
79072-96-1
743
38950
yes
no
Details
200-945-0
76-22-2
136
41680
yes
no
Details
231-153-3
7440-44-0
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).
Details
200-870-3
75-44-5
133
23155
14380
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
231-959-5
7782-50-5
522
14530
no
no
Details
200-871-9
75-45-6
134
43680
yes
no
6 mg/kg
Content of chlorofluoromethane less than 1 mg/kg of the substance.
Details
201-201-8
79-38-9
148
14650
no
no
0.01 mg/kg
Details
201-069-1
77-92-9
139
44160
14680
yes
no
Details
201-070-7
77-93-0
140
44640
yes
no
Details
232-131-6
7787-70-4
523
45195
yes
no
Details
200-815-3
74-85-1
125
16950
no
no
Details
200-849-9
75-21-8
129
17020
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
451-530-8
736150-63-3
783
55910
yes
no
Details
201-180-5
79-14-1
794
18117
no
no
Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.
Details
231-955-3
7782-42-5
521
58320
yes
no
Details
231-595-7
7647-01-0
507
59990
yes
no
Details
200-857-2
75-28-5
1069
yes
no
Only to be used as a blowing agent.
Details
201-142-8
78-78-4
143
62450
yes
no
Details
231-869-6
7773-01-5
520
65120
yes
no
Details
201-202-3
79-39-0
149
19990
no
no
0.01 mg/kg
Details
201-204-4
79-41-4
150
20020
no
no
Details
212-084-8
760-93-0
370
21460
no
no
Details
231-633-2
7664-38-2
509
23170
72640
yes
no
Details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details
680-598-3
70142-34-6
737
77370
yes
no
Details
231-830-3
7758-02-3
517
81520
yes
no
Details
231-659-4
7681-11-0
512
81680
yes
no
Details
201-176-3
79-09-4
146
82000
23890
yes
no
Details
200-879-2
75-56-9
135
24010
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
277-299-1
73138-82-6
741
83610
24070
yes
no
Details
231-545-4
7631-86-9
504
86240
yes
no
For synthetic amorphous silicon dioxide: primary particles of 1 - 100 nm which are aggregated to a size of 0,1 - 1 µm which may form agglomerates within the size distribution of 0,3 µm to the mm size.
Details
231-548-0
7631-90-5
505
86480
yes
no
Details
231-599-9
7647-15-6
508
86560
yes
no
Details
231-679-3
7681-82-5
513
86800
yes
no
Details
231-555-9
7632-00-0
506
86920
yes
no
0.6 mg/kg
Details
231-821-4
7757-83-7
516
86960
yes
no
Details
231-867-5
7772-98-7
519
87120
yes
no
Details
231-722-6
7704-34-9
514
91840
yes
no
Details
231-639-5
7664-93-9
511
91920
yes
no
Details
231-710-0
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
201-067-0
77-90-7
138
93760
yes
no
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
Details
200-867-7
75-38-7
132
26140
no
no
5 mg/kg
Details
201-081-7
78-08-0
142
26305
no
no
0.05 mg/kg
Only to be used as a surface treatment agent.
Details
231-791-2
7732-18-5
515
95855
26360
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
Details
231-493-2
7585-39-9
503
46080
yes
no
Details
617-241-8
81541-12-0
752
39890
yes
no
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
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
279-459-6
80410-33-9
745
68145
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
286-344-4
85209-91-2
749
66360
yes
yes
5 mg/kg
Details
201-814-0
88-24-4
163
66400
yes
yes
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details
201-245-8
80-05-7
151
13480
13607
no
no
0.05 mg/kg
Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union].
Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].
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
212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
Details
201-851-2
88-68-6
164
34895
yes
no
0.05 mg/kg
Only for use in PET for water and beverages.
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
201-248-4
80-08-0
153
15267
no
no
5 mg/kg
Details
201-247-9
80-07-9
152
15610
no
no
0.05 mg/kg
Details
201-250-5
80-09-1
154
13617
16090
no
no
0.05 mg/kg
Details
212-454-9
818-61-1
371
11830
11510
no
no
Details
The wax obtained from the honeycomb of the bee. It consists primarily of myricyl palmitate, cerotic acid and esters and some high-carbon paraffins.
232-383-7
8012-89-3
531
36880
yes
no
Details
ADK STAB PEP-36
410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
283-829-2
84731-70-4
1079
yes
no
0.05 mg/kg
Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.
Details
618-128-6
882073-43-0
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
402-950-5
87826-41-3
752
39890
yes
no
Details
The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.
232-347-0
8006-44-8
530
41760
yes
no
Details
The wax derived from Copernicia cerifera, Palmae.
232-399-4
8015-86-9
533
42720
yes
no
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic. (Ricinus communis, Euphorbiaceae).
232-293-8
8001-79-4
527
42880
14411
yes
no
Details
A complex combination of hydrocarbons produced by the purification of ozocerite with sulfuric acid and filtration through bone black to form waxy cakes.
232-290-1
8001-75-0
526
43440
yes
no
Details
281-837-0
84030-61-5
747
47600
yes
yes
Details
212-485-8
822-06-0
372
18640
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
-
8001-39-6
525
62640
yes
no
Details
201-766-0
87-69-4
161
92160
yes
no
Details
The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.
232-307-2
8002-43-5
528
63760
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
201-770-2
87-78-5
162
65520
yes
no
Details
201-297-1
80-62-6
156
21130
no
no
Details
212-782-2
868-77-9
374
21190
no
no
Details
288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
Details
Wax obtained by extraction of lignite.
232-313-5
8002-53-7
529
67850
yes
no
Details
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
282-811-1
84434-12-8
748
12765
no
no
0.05 mg/kg
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
201-873-2
88-99-3
192
23187
no
no
Details
201-873-2
88-99-3
165
23200
74480
yes
no
Details
201-622-7
85-68-7
159
74560
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
201-622-7
85-68-7
159
74560
yes
no
6 mg/kg
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
201-622-7
85-68-7
159
74560
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
0.12 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-607-5
85-44-9
158
23380
76320
yes
no
Details
700-107-9
87189-25-1
751
81515
yes
no
Details
232-417-0
8017-16-1
534
80720
yes
no
Details
201-898-9
89-32-7
166
24057
no
no
0.05 mg/kg
Details
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
535
24100
24190
83840
24130
yes
no
Details
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
539
24160
no
no
Details
232-482-5
8050-31-5
538
84000
yes
no
Details
232-479-9
8050-26-8
537
84080
yes
no
Details
232-476-2
8050-15-5
536
84320
yes
no
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).
232-274-4
8001-22-7
524
24520
no
no
Details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
232-391-0
8013-07-8
532
88640
yes
no
Details
232-391-0
8013-07-8
532
88640
yes
no
30 mg/kg
In the case of PVC gaskets used to seal glass jars containing 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, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
201-291-9
80-56-8
155
23470
no
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
618-414-0
9005-37-2
567
82080
yes
no
Details

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