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 25 June 2024. Database contains 1080 unique substances/entries.
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88
86880
yes
no
9 mg/kg
Details
253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
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
203-400-5
106-46-7
217
15565
no
no
12 mg/kg
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
203-545-4
108-05-4
231
10120
no
no
12 mg/kg
Details
209-530-9
584-09-8
353
42480
yes
no
12 mg/kg
Details
-
-
25
45440
yes
no
12 mg/kg
Details
203-468-6
107-15-3
226
16960
15272
no
no
12 mg/kg
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
251-156-3
32687-78-8
675
38800
yes
yes
15 mg/kg
Details
-
-
91
92320
yes
yes
15 mg/kg
Details
203-090-1
103-23-1
207
31920
yes
yes
18 mg/kg
Details
264-122-8
63397-60-4
710
38700
yes
yes
18 mg/kg
Details
203-542-8
108-01-0
230
16150
no
no
18 mg/kg
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
254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
203-234-3
104-76-7
209
17050
no
no
30 mg/kg
Details
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-
15
34130
yes
yes
30 mg/kg
Details
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-
209
17050
no
no
30 mg/kg
Details
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-
658
52000
yes
no
30 mg/kg
Details
248-289-4
27176-87-0
658
52000
yes
no
30 mg/kg
Details
202-510-0
96-49-1
177
16955
no
no
30 mg/kg
SML expressed as ethyleneglycol.
Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.
Details
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14
33801
yes
no
30 mg/kg
Details
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-
69
74400
yes
yes
30 mg/kg
Details
204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
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
246-563-8
25013-16-5
635
40720
yes
no
30 mg/kg
Details
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324
83700
yes
yes
42 mg/kg
Details
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74
77440
yes
yes
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
Details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
Details
617-241-8
81541-12-0
752
39890
yes
no
Details
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1043
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
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859
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
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998
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
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855
40560
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
Details

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