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 29 March 2024. Database contains 1080 unique substances/entries.
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604-479-2
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
229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
Details
221-140-0
3010-96-6
881
25187
no
no
5 mg/kg
Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
Details
-
78301-43-6
742
92700
yes
yes
5 mg/kg
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details
286-344-4
85209-91-2
749
66360
yes
yes
5 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
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
203-694-5
109-67-1
245
22900
no
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
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
214-068-6
1076-97-7
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
Details
456-830-2
745070-61-5
784
95420
yes
no
5 mg/kg
Details
500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
Details
252-816-3
35958-30-6
679
39060
yes
yes
5 mg/kg
Details
217-420-7
1843-03-4
430
95600
yes
yes
5 mg/kg
Details
-
-
477
46720
yes
yes
4.8 mg/kg
Details
223-945-2
4130-42-1
477
46720
yes
yes
4.8 mg/kg
Details
245-818-0
23676-09-7
632
52880
yes
no
3.6 mg/kg
Details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
Details
203-632-7
108-95-2
241
22960
no
no
3 mg/kg
Details
203-004-2
102-08-9
200
51680
yes
yes
3 mg/kg
Details
204-853-1
127-63-9
313
51570
16650
yes
no
3 mg/kg
Details
-
-
241
22960
no
no
3 mg/kg
Details
-
-
315
46640
yes
no
3 mg/kg
Details
204-881-4
128-37-0
315
46640
yes
no
3 mg/kg
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
203-615-4
108-78-1
239
25420
19975
93720
yes
no
2.5 mg/kg
Details
255-392-8
41484-35-9
690
92880
yes
yes
2.4 mg/kg
Details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
Details
-
61269-61-2
701
40160
yes
no
2.4 mg/kg
Details
204-679-6
124-09-4
305
18460
15274
no
no
2.4 mg/kg
Details
203-585-2
108-46-3
237
24072
15910
no
no
2.4 mg/kg
Details
-
-
814
91815
yes
no
2 mg/kg
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
-
-
799
77708
yes
no
1.8 mg/kg
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
Details
228-253-4
6200-40-4
493
39200
yes
no
1.8 mg/kg
Details
256-318-7
47465-97-4
691
13600
no
no
1.8 mg/kg
Details
274-570-6
70321-86-7
738
60320
yes
yes
1.5 mg/kg
Details
222-020-0
3319-31-1
1078
yes
no
1 mg/kg
Only to be used as plasticiser to manufacture soft poly(vinyl chloride).
Not to be used in contact with foods intended for infants.
Details
700-485-5
939402-02-5
974
74050
yes
yes
1 mg/kg
The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.
Details
-
-
765
49485
yes
yes
1 mg/kg
Details
CG 27-145
411-220-5
134701-20-5
765
49485
yes
yes
1 mg/kg
Details
-
-
23
43515
yes
no
0.9 mg/kg
Details
203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
Details
231-555-9
7632-00-0
506
86920
yes
no
0.6 mg/kg
Details
204-211-0
117-81-7
283
74640
yes
no
0.6 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
Details
614-830-1
68951-50-8
735
40120
yes
no
0.6 mg/kg
Details

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