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 03 December 2021. Database contains 1072 unique substances/entries.
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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).
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412-440-4
2725-22-6
452
38885
yes
no
5 mg/kg
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438-600-3
110675-26-8
758
38940
yes
yes
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CG 25-1320; IRGANOX 1520; TK 12229/1
402-860-6
110553-27-0
756
40020
yes
yes
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411-220-5
134701-20-5
765
49485
yes
yes
1 mg/kg
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CG 30-1577
411-380-6
147315-50-2
770
51700
yes
no
0.05 mg/kg
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455-890-7
6607-41-6
872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
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430-800-9
129228-21-3
763
39925
yes
yes
0.05 mg/kg
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3,4-DIACETOXY-1-BUTENE
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.
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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.
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ANOX 1315; ANOX BF; DURAD AX 38
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.
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402-130-7
106246-33-7
755
21765
no
no
0.05 mg/kg
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431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
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413-850-6
123968-25-2
762
31530
yes
yes
5 mg/kg
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430-650-4
151841-65-5
771
34650
yes
no
5 mg/kg
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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.
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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).
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410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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413-110-2
135861-56-2
766
38879
yes
no
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NC-4
406-176-9
79072-96-1
743
38950
yes
no
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CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
402-950-5
87826-41-3
752
39890
yes
no
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451-530-8
736150-63-3
783
55910
yes
no
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CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
791
92470
yes
no
0.05 mg/kg
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481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
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419-710-0
42774-15-2
1051
yes
no
5 mg/kg
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LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
795
40155
yes
no
0.05 mg/kg
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429-160-3
178671-58-4
778
71670
yes
yes
0.05 mg/kg
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416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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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.
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406-060-8
110638-71-6
757
95725
yes
no
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500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
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500-231-1
68783-41-5
733
10599/92A
10599/93
no
no
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500-148-0
61788-89-4
705
10599/91
10599/90A
no
no
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500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
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1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
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1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
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1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
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1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
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1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
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1 - 4.5 moles propoxylated
500-039-8
25322-69-4
639
23651
80800
yes
no
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617-241-8
81541-12-0
752
39890
yes
no
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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.
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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 %.
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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.
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618-414-0
9005-37-2
567
82080
yes
no
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616-108-1
745070-61-5
784
95420
yes
no
5 mg/kg
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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.
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613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
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688-151-4
118337-09-0
759
54300
yes
yes
6 mg/kg
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617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
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