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 16 December 2020. Database contains 1072 unique substances/entries.
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204-881-4
128-37-0
315
46640
yes
no
3 mg/kg
Details
-
-
315
46640
yes
no
3 mg/kg
Details
-
-
241
22960
no
no
3 mg/kg
Details
204-853-1
127-63-9
313
51570
16650
yes
no
3 mg/kg
Details
203-004-2
102-08-9
200
51680
yes
yes
3 mg/kg
Details
203-632-7
108-95-2
241
22960
no
no
3 mg/kg
Details
615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
Details
245-818-0
23676-09-7
632
52880
yes
no
3.6 mg/kg
Details
223-945-2
4130-42-1
477
46720
yes
yes
4.8 mg/kg
Details
-
-
477
46720
yes
yes
4.8 mg/kg
Details
217-420-7
1843-03-4
430
95600
yes
yes
5 mg/kg
Details
252-816-3
35958-30-6
679
39060
yes
yes
5 mg/kg
Details
500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
Details
616-108-1
745070-61-5
784
95420
yes
no
5 mg/kg
Details
248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
214-068-6
1076-97-7
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
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
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
203-694-5
109-67-1
245
22900
no
no
5 mg/kg
Details
219-417-6
2432-99-7
443
12788
no
no
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
286-344-4
85209-91-2
749
66360
yes
yes
5 mg/kg
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details
-
78301-43-6
742
92700
yes
yes
5 mg/kg
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
229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
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
200-254-4
56-06-4
864
46330
yes
no
5 mg/kg
Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.
Details
202-095-6
91-76-9
168
13075
15310
no
no
5 mg/kg
Details
214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
Details
-
203255-81-6
792
92475
yes
yes
5 mg/kg
SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products.
Details
201-248-4
80-08-0
153
15267
no
no
5 mg/kg
Details
-
-
26
46700
yes
no
5 mg/kg
Details
-
-
823
24889
no
no
5 mg/kg
Details
229-662-0
6642-31-5
495
35160
yes
no
5 mg/kg
Details
204-432-2
120-87-6
27
48960
yes
no
5 mg/kg
Details
-
-
27
48960
yes
no
5 mg/kg
Details
413-850-6
123968-25-2
762
31530
yes
yes
5 mg/kg
Details
604-520-4
146340-15-0
802
33105
yes
no
5 mg/kg
Details
-
-
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
-
-
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
-
-
443
12788
no
no
5 mg/kg
Details
-
-
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
-
-
389
22360
no
no
5 mg/kg
Details
-
-
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
-
-
1031
no
no
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.
The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).
Details
430-650-4
151841-65-5
771
34650
yes
no
5 mg/kg
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

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