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 18 May 2021. Database contains 1072 unique substances/entries.
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203-584-7
108-45-2
236
23050
no
no
0.01 mg/kg
Details
207-997-3
504-63-2
343
23770
no
no
0.05 mg/kg
Details
203-268-9
105-08-8
210
13390
14880
no
no
Details
203-786-5
110-63-4
254
13720
40580
yes
no
Details
219-371-7
2425-79-8
442
13780
no
no
0.01 mg/kg
Residual content = 1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
208-015-6
505-65-7
344
21821
13810
no
no
0.05 mg/kg
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
214-068-6
1076-97-7
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
203-782-3
110-60-1
253
15250
no
no
Details
203-400-5
106-46-7
217
15565
no
no
12 mg/kg
Details
204-617-8
123-31-9
295
18867
15940
48620
yes
no
0.6 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
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
223-054-9
3710-30-3
1034
no
no
0.05 mg/kg
Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.
Details
216-711-6
1647-16-1
424
15070
no
no
0.05 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
223-805-0
4080-31-3
474
43600
yes
no
0.3 mg/kg
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
200-751-6
71-36-3
123
13840
no
no
Details
203-449-2
106-98-9
222
13870
no
no
Details
203-956-9
112-30-1
267
15100
no
no
Details
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
203-968-4
112-41-4
268
16704
no
no
0.05 mg/kg
Details
253-149-0
36653-82-4
681
18310
no
no
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
223-861-6
4098-71-9
475
19110
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
205-583-7
143-08-8
331
22480
no
no
Details
203-917-6
111-87-5
265
22600
no
no
Details
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
200-752-1
71-41-0
124
22870
no
no
Details
203-694-5
109-67-1
245
22900
no
no
5 mg/kg
Details
200-746-9
71-23-8
122
23800
no
no
Details
214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
Details
214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
Details
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
203-366-1
106-14-9
214
61840
yes
no
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details
274-572-7
70331-94-1
739
70000
yes
no
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
201-245-8
80-05-7
151
13607
13480
no
no
0.05 mg/kg
Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union].
Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].
Details
216-823-5
1675-54-3
426
13510
13610
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
Details
253-781-7
38103-06-9
687
13614
13530
no
no
0.05 mg/kg
Details
225-306-3
4767-03-7
484
13395
no
no
0.05 mg/kg
Details
204-781-0
126-30-7
310
22437
16390
no
no
0.05 mg/kg
Details
-
1547-26-8
1063
no
no
Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
Details

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