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 28 March 2024. Database contains 1080 unique substances/entries.
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200-815-3
74-85-1
125
16950
no
no
Details
451-530-8
736150-63-3
783
55910
yes
no
Details
277-299-1
73138-82-6
741
83610
24070
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
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
Details
230-426-4
7128-64-5
500
38560
yes
yes
0.6 mg/kg
Details
200-752-1
71-41-0
124
22870
no
no
Details
200-751-6
71-36-3
123
13840
no
no
Details
200-746-9
71-23-8
122
23800
no
no
Details
274-572-7
70331-94-1
739
70000
yes
no
Details
274-570-6
70321-86-7
738
60320
yes
yes
1.5 mg/kg
Details
680-598-3
70142-34-6
737
77370
yes
no
Details
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
211-750-5
693-36-7
368
93280
yes
yes
Details
211-746-3
693-23-2
367
16697
no
no
Details
-
69226-46-6
30
50560
yes
no
Details
-
69158-41-4
752
39890
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
211-720-1
691-37-2
366
22150
no
no
0.05 mg/kg
Details
614-830-1
68951-50-8
735
40120
yes
no
0.6 mg/kg
Details
211-710-7
689-12-3
365
11680
no
no
Details
272-489-0
68855-54-9
734
46380
yes
no
Details
500-231-1
68783-41-5
733
10599/93
10599/92A
no
no
Details
229-962-1
6864-37-5
498
16210
no
no
0.05 mg/kg
Only to be used in polyamides.
Details
271-867-2
68610-51-5
732
45450
yes
yes
5 mg/kg
Details
271-487-7
68564-88-5
731
18220
no
no
0.05 mg/kg
Details
614-610-5
68554-70-1
730
66930
yes
no
Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.
Details
271-091-4
68515-49-1
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.
Details
271-091-4
68515-49-1
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.
Details
271-090-9
68515-48-0
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
271-090-9
68515-48-0
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
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
270-476-4
68442-12-6
726
83599
yes
yes
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
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
686-629-7
68412-29-3
723
88880
yes
no
Details
269-657-0
68308-53-2
722
17200
no
no
Details
268-500-3
68109-88-6
29
50360
yes
no
Details
267-342-2
67845-93-6
721
46800
yes
no
Details
266-836-5
67649-65-4
720
67360
yes
no
Details
200-664-3
67-68-5
120
49540
yes
no
Details
200-662-2
67-64-1
119
30295
yes
no
Details
200-661-7
67-63-0
118
81882
23830
yes
no
Details
200-659-6
67-56-1
117
21550
no
no
Details
229-722-6
6683-19-8
496
71680
yes
no
Details
-
66822-60-4
719
65920
yes
no
Details
229-662-0
6642-31-5
495
35160
yes
no
5 mg/kg
Details
-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
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
266-042-9
65997-13-9
718
84240
yes
no
Details
266-041-3
65997-06-0
717
84210
yes
no
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
211-492-3
652-67-5
364
15404
no
no
5 mg/kg
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
Details
265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
Details
200-618-2
65-85-0
116
37600
13090
yes
no
Details
211-471-9
646-25-3
863
15260
no
no
0.05 mg/kg
Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
264-848-5
64365-17-9
714
84400
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
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
264-705-7
64147-40-6
712
42960
yes
no
Details
200-580-7
64-19-7
115
30000
10090
yes
no
Details
200-579-1
64-18-6
114
55040
yes
no
Details
200-578-6
64-17-5
113
52800
16780
yes
no
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
264-122-8
63397-60-4
710
38700
yes
yes
18 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
228-601-5
6303-21-5
494
62140
yes
no
Details
211-128-3
630-08-0
362
14350
no
no
Details
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
263-600-3
62568-11-0
709
87520
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
228-253-4
6200-40-4
493
39200
yes
no
1.8 mg/kg
Details
210-647-2
620-67-7
360
57920
yes
no
Details
228-250-8
6197-30-4
492
45650
yes
no
0.05 mg/kg
Details
228-229-3
6182-11-2
491
82720
yes
no
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
263-107-3
61790-12-3
706
17230
no
no
Details
500-148-0
61788-89-4
705
10599/91
10599/90A
no
no
Details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
Details
262-978-7
61788-47-4
703
17170
no
no
Details
262-958-8
61752-68-9
702
87920
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
-
61269-61-2
701
40160
yes
no
2.4 mg/kg
Details
262-634-6
61167-58-6
700
31520
yes
yes
6 mg/kg
Details
210-288-1
611-99-4
359
15970
48720
yes
no
Details
200-470-9
60-33-3
112
64015
yes
no
Details
200-449-4
60-00-4
111
53600
yes
no
Details
209-968-0
599-64-4
358
14841
no
no
0.05 mg/kg
Details
209-929-8
598-32-3
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
200-412-2
59-02-9
110
93520
yes
no
Details
227-534-9
5873-54-1
490
16600
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
261-327-4
58561-47-0
52
56580
yes
no
Details
209-548-7
585-07-9
355
20170
no
no
Details
261-257-4
58446-52-9
699
90720
yes
no
Details

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