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 23 April 2024. Database contains 1080 unique substances/entries.
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209-249-1
563-45-1
351
21730
no
no
0.01 mg/kg
Only to be used in polypropylene.
Details
224-709-1
4457-71-0
883
22074
no
no
0.05 mg/kg
Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg.
Details
616-996-0
80181-31-3
744
18888
no
no
The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.
Details
204-179-8
117-21-5
786
14627
no
no
0.05 mg/kg
SML expressed as 3-chlorophthalic acid.
Details
209-929-8
598-32-3
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
213-048-4
919-30-2
377
12786
no
no
0.05 mg/kg
Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers.
SML = 0,05 mg/kg when used for the surface treatment of materials and articles.
Details
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.
Details
256-318-7
47465-97-4
691
13600
no
no
1.8 mg/kg
Details
202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
229-962-1
6864-37-5
498
16210
no
no
0.05 mg/kg
Only to be used in polyamides.
Details
455-890-7
6607-41-6
872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
Details
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
203-234-3
104-76-7
209
17050
no
no
30 mg/kg
Details
203-452-9
107-01-7
224
13900
no
no
Details
239-268-0
15214-89-8
617
10660
no
no
0.05 mg/kg
Details
202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
Details
214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
Details
209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
Details
247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
202-095-6
91-76-9
168
13075
15310
no
no
5 mg/kg
Details
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
813-638-7
80512-44-3
1061
no
no
Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.
Details
219-330-3
2416-94-6
882
25872
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
204-781-0
126-30-7
310
16390
22437
no
no
0.05 mg/kg
Details
225-306-3
4767-03-7
484
13395
no
no
0.05 mg/kg
Details
253-781-7
38103-06-9
687
13614
13530
no
no
0.05 mg/kg
Details
216-823-5
1675-54-3
426
13610
13510
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
Details
201-245-8
80-05-7
151
13480
13607
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
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
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
Details
214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
Details
200-746-9
71-23-8
122
23800
no
no
Details
203-694-5
109-67-1
245
22900
no
no
5 mg/kg
Details
200-752-1
71-41-0
124
22870
no
no
Details
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
203-917-6
111-87-5
265
22600
no
no
Details
205-583-7
143-08-8
331
22480
no
no
Details
223-861-6
4098-71-9
475
19110
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
253-149-0
36653-82-4
681
18310
no
no
Details
203-968-4
112-41-4
268
16704
no
no
0.05 mg/kg
Details
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
203-956-9
112-30-1
267
15100
no
no
Details
203-449-2
106-98-9
222
13870
no
no
Details
200-751-6
71-36-3
123
13840
no
no
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
216-711-6
1647-16-1
424
15070
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
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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
203-400-5
106-46-7
217
15565
no
no
12 mg/kg
Details
203-782-3
110-60-1
253
15250
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
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
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
203-268-9
105-08-8
210
13390
14880
no
no
Details
207-997-3
504-63-2
343
23770
no
no
0.05 mg/kg
Details
203-584-7
108-45-2
236
23050
no
no
0.01 mg/kg
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
203-585-2
108-46-3
237
24072
15910
no
no
2.4 mg/kg
Details
203-529-7
107-88-0
228
13690
no
no
Details
222-852-4
3634-83-1
988
no
no
SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine.
To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.
Details
203-028-3
102-40-9
203
13323
no
no
0.05 mg/kg
Details
216-032-5
1477-55-0
421
13000
no
no
Details
224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
Details
204-427-5
120-80-9
289
24051
15880
no
no
6 mg/kg
Details
-
23985-75-3
1066
no
no
0.05 mg/kg
Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III.
The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).
Details
211-471-9
646-25-3
863
15260
no
no
0.05 mg/kg
Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.
Details
THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE
405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
221-950-4
3290-92-4
463
25840
no
no
0.05 mg/kg
Details
243-053-7
19430-93-4
973
22931
no
no
Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.
Details
203-027-8
102-39-6
202
23070
no
no
0.05 mg/kg
Details

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