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 17 June 2021. Database contains 1072 unique substances/entries.
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203-027-8
102-39-6
202
23070
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
221-950-4
3290-92-4
463
25840
no
no
0.05 mg/kg
Details
405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
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
-
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
204-427-5
120-80-9
289
15880
24051
no
no
6 mg/kg
Details
224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
Details
216-032-5
1477-55-0
421
13000
no
no
Details
203-028-3
102-40-9
203
13323
no
no
0.05 mg/kg
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
203-529-7
107-88-0
228
13690
no
no
Details
203-585-2
108-46-3
237
15910
24072
no
no
2.4 mg/kg
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
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
14880
13390
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
208-015-6
505-65-7
344
13810
21821
no
no
Details
208-015-6
505-65-7
344
13810
21821
no
no
Details
208-015-6
505-65-7
344
13810
21821
no
no
0.05 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
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
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
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
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
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
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
13530
13614
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
16390
22437
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
219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
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
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
202-095-6
91-76-9
168
15310
13075
no
no
5 mg/kg
Details
209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
Details
214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
Details
212-661-4
840-65-3
373
22390
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
239-268-0
15214-89-8
617
10660
no
no
0.05 mg/kg
Details
203-452-9
107-01-7
224
13900
no
no
Details
203-234-3
104-76-7
209
17050
no
no
30 mg/kg
Details
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
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
229-962-1
6864-37-5
498
16210
no
no
0.05 mg/kg
Only to be used in polyamides.
Details
202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
256-318-7
47465-97-4
691
13600
no
no
1.8 mg/kg
Details
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
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
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
204-179-8
117-21-5
786
14627
no
no
0.05 mg/kg
SML expressed as 3-chlorophthalic acid.
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
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
209-249-1
563-45-1
351
21730
no
no
0.01 mg/kg
Only to be used in polypropylene.
Details
201-248-4
80-08-0
153
15267
no
no
5 mg/kg
Details
201-247-9
80-07-9
152
15610
no
no
0.05 mg/kg
Details
206-466-3
345-92-6
337
15820
no
no
0.05 mg/kg
Details
202-200-5
92-88-6
170
16000
no
no
6 mg/kg
Details
201-250-5
80-09-1
154
16090
13617
no
no
0.05 mg/kg
Details
402-130-7
106246-33-7
755
21765
no
no
0.05 mg/kg
Details
431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
Details
216-847-6
1679-51-2
427
18896
no
no
0.05 mg/kg
Details
204-251-9
118-45-6
787
14628
no
no
0.05 mg/kg
SML expressed as 4-chlorophthalic acid.
Details
209-968-0
599-64-4
358
14841
no
no
0.05 mg/kg
Details
211-720-1
691-37-2
366
22150
no
no
0.05 mg/kg
Details
202-679-0
98-54-4
186
14020
no
no
0.05 mg/kg
Details
240-347-7
16219-75-3
621
17110
no
no
0.05 mg/kg
Details
223-578-8
3965-55-7
471
24888
no
no
0.05 mg/kg
Details
-
-
823
24889
no
no
5 mg/kg
Details
240-759-7
16712-64-4
624
18897
no
no
0.05 mg/kg
Details
219-784-2
2530-83-8
1068
no
no
Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).
Details
219-785-8
2530-85-0
788
21498
no
no
0.05 mg/kg
Only to be used as a surface treatment agent of inorganic fillers.
Details
208-178-3
514-10-3
346
10030
no
no
Details
200-836-8
75-07-0
128
10060
no
no
Details

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