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 22 June 2021. Database contains 1072 unique substances/entries.
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255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
Details
204-614-1
123-28-4
294
93120
yes
yes
Details
211-750-5
693-36-7
368
93280
yes
yes
Details
240-613-2
16545-54-3
894
93360
yes
no
Details
236-675-5
13463-67-7
610
93440
yes
no
Details
234-354-4
11116-16-8
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
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
257-757-7
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
232-552-5
9000-65-1
545
93680
yes
no
Details
201-067-0
77-90-7
138
93760
yes
no
Details
203-048-2
102-70-5
205
25385
no
no
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.
Only to be used in hydrogels intended for non-direct food contact use.
Details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
Details
203-049-8
102-71-6
793
94000
yes
no
0.05 mg/kg
SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine.
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
203-953-2
112-27-6
266
25510
94320
yes
no
Details
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
Details
204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
Details
208-432-3
528-44-9
347
13050
25540
no
no
Details
209-008-0
552-30-7
349
25550
no
no
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
203-812-5
110-88-3
255
25900
no
no
5 mg/kg
Details
246-466-0
24800-44-0
634
25910
no
no
Details
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
Details
200-315-5
57-13-6
107
25960
no
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
220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
Details
231-791-2
7732-18-5
515
26360
95855
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
Details
237-772-5
13983-17-0
613
95905
yes
no
Details
234-394-2
11138-66-2
596
95935
yes
no
Details
243-814-3
20427-58-1
628
96190
yes
no
Details
215-222-5
1314-13-2
402
96240
yes
no
Details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
Details
215-222-5
1314-13-2
1046
yes
no
Only to be used in unplasticised polymers.
The restrictions and specifications specified for FCM substance No 788 shall be respected.
Details
215-251-3
1314-98-3
403
96320
yes
no
Details
233-007-4
10016-20-3
580
46070
yes
no
Details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
Details
201-291-9
80-56-8
155
23470
no
no
Details
231-493-2
7585-39-9
503
46080
yes
no
Details
204-872-5
127-91-3
314
23500
no
no
Details
A clay that is essentially kaolinite, a hydrated aluminum silicate. It has a high fusion point and is the most refractory of all clays.
310-194-1
1332-58-7
410
62720
yes
no
Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi- layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.
Details
405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
431-890-2
166412-78-8
775
45705
yes
no
Details
418-280-1
18600-59-4
796
72141
yes
yes
0.05 mg/kg
SML including the sum of its hydrolysis products.
Details
423-560-1
161717-32-4
774
95270
yes
yes
2 mg/kg
SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP.
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
412-440-4
2725-22-6
452
38885
yes
no
5 mg/kg
Details
438-600-3
110675-26-8
758
38940
yes
yes
Details
CG 25-1320; IRGANOX 1520; TK 12229/1
402-860-6
110553-27-0
756
40020
yes
yes
Details
411-220-5
134701-20-5
765
49485
yes
yes
1 mg/kg
Details
CG 30-1577
411-380-6
147315-50-2
770
51700
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
430-800-9
129228-21-3
763
39925
yes
yes
0.05 mg/kg
Details
421-720-5
18085-02-4
862
15180
no
no
0.05 mg/kg
SML including the hydrolysis product 3,4- dihydroxy-1-butene.
Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.
Details
410-730-5
90498-90-1
858
38565
yes
yes
0.05 mg/kg
SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer.
Details
413-750-2
171090-93-0
895
47060
yes
no
0.05 mg/kg
Only to be used in polyolefins in contact with foods other than fatty/ high-alcoholic and dairy products.
Details
402-130-7
106246-33-7
755
21765
no
no
0.05 mg/kg
Details
431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
Details
413-850-6
123968-25-2
762
31530
yes
yes
5 mg/kg
Details
430-650-4
151841-65-5
771
34650
yes
no
5 mg/kg
Details
418-370-0
143925-92-2
768
34850
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.
Details
421-920-2
154862-43-8
773
38840
yes
yes
5 mg/kg
SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol).
Details
410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
413-110-2
135861-56-2
766
38879
yes
no
Details
NC-4
406-176-9
79072-96-1
743
38950
yes
no
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
451-530-8
736150-63-3
783
55910
yes
no
Details
401-990-0
106990-43-6
791
92470
yes
no
0.05 mg/kg
Details
481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
Details
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
Details
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
795
40155
yes
no
0.05 mg/kg
Details
429-160-3
178671-58-4
778
71670
yes
yes
0.05 mg/kg
Details
416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
432-130-2
119345-01-6
760
83595
yes
no
18 mg/kg
Composition: 4,4'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)),4,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)),3,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)),4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)),tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)),4,4'-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))(*)Quantity of substance used/quantity of formulationOther specifications: Phosphor content of min. 5,4 % to max. 5,9 %,Acid value of max. 10 mg KOH per gram,Melt range of 85- 110 °C.
Details
406-060-8
110638-71-6
757
95725
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
500-148-0
61788-89-4
705
10599/90A
10599/91
no
no
Details
500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
Details
1 - 4.5 moles ethoxylated
500-038-2
25322-68-3
638
23590
76960
yes
no
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
1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
Details
1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
Details
1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
Details
1 - 4.5 moles propoxylated
500-039-8
25322-69-4
639
23651
80800
yes
no
Details
617-241-8
81541-12-0
752
39890
yes
no
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
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
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
616-108-1
745070-61-5
784
95420
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
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
688-151-4
118337-09-0
759
54300
yes
yes
6 mg/kg
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
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
682-678-3
182121-12-6
779
39815
yes
yes
0.05 mg/kg
Details

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