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 28 March 2024. Database contains 1080 unique substances/entries.
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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
-
-
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
203-584-7
108-45-2
236
23050
no
no
0.01 mg/kg
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
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
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
209-249-1
563-45-1
351
21730
no
no
0.01 mg/kg
Only to be used in polypropylene.
Details
201-173-7
79-06-1
145
10630
no
no
0.01 mg/kg
Details
203-466-5
107-13-1
225
12100
no
no
0.01 mg/kg
Details
223-792-1
4074-90-2
473
12265
no
no
0.01 mg/kg
5 mg/kg in final product.
Only to be used as co-monomer.
Details
-
-
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
-
-
278
18250
no
no
0.01 mg/kg
Details
203-450-8
106-99-0
223
13630
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-870-3
75-44-5
133
23155
14380
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
201-201-8
79-38-9
148
14650
no
no
0.01 mg/kg
Details
215-325-5
1321-74-0
405
16690
no
no
0.01 mg/kg
SML expressed as the sum of divinylbenzene and ethylvinylbenzene.
It may contain up to 45 % (m/m) of ethylvinylbenzene
Details
203-439-8
106-89-8
219
14570
16750
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-849-9
75-21-8
129
17020
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
205-793-9
151-56-4
334
17005
no
no
0.01 mg/kg
Details
204-078-9
115-28-6
278
18250
no
no
0.01 mg/kg
Details
204-077-3
115-27-5
277
18280
no
no
0.01 mg/kg
Details
204-127-4
116-15-4
282
18430
no
no
0.01 mg/kg
Details
201-202-3
79-39-0
149
19990
no
no
0.01 mg/kg
Details
220-688-8
2867-47-2
455
20530
no
no
0.01 mg/kg
Details
234-207-4
10595-80-9
590
21370
no
no
0.01 mg/kg
Details
204-817-5
126-98-7
312
21490
no
no
0.01 mg/kg
Details
213-103-2
924-42-5
379
21940
no
no
0.01 mg/kg
Details
204-118-5
115-96-8
280
73720
yes
no
0.01 mg/kg
Details
204-552-5
122-52-1
293
23175
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
205-016-3
131-17-9
316
23230
no
no
0.01 mg/kg
Details
200-879-2
75-56-9
135
24010
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
202-987-5
101-90-6
199
24073
no
no
0.01 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
For indirect food contact only, behind a PET layer.
Details
-
-
5
25360
no
no
0.01 mg/kg
1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
Details
203-441-9
106-91-2
220
20590
no
no
0.02 mg/kg
Details
221-698-5
3195-78-6
462
26170
no
no
0.02 mg/kg
Details
203-027-8
102-39-6
202
23070
no
no
0.05 mg/kg
Details
221-950-4
3290-92-4
463
25840
no
no
0.05 mg/kg
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
224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
Details
-
227099-60-7
781
95265
yes
no
0.05 mg/kg
Details
203-028-3
102-40-9
203
13323
no
no
0.05 mg/kg
Details
207-997-3
504-63-2
343
23770
no
no
0.05 mg/kg
Details
208-015-6
505-65-7
344
21821
13810
no
no
0.05 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
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
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
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
796
72141
yes
yes
0.05 mg/kg
SML including the sum of its hydrolysis products.
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
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
16390
22437
no
no
0.05 mg/kg
Details
219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
Details
209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
Details
212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
Details
CG 30-1577
411-380-6
147315-50-2
770
51700
yes
no
0.05 mg/kg
Details
239-268-0
15214-89-8
617
10660
no
no
0.05 mg/kg
Details
201-851-2
88-68-6
164
34895
yes
no
0.05 mg/kg
Only for use in PET for water and beverages.
Details
205-483-3
141-43-5
326
35170
12763
yes
no
0.05 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
For indirect food contact only, behind a PET layer.
Details
228-250-8
6197-30-4
492
45650
yes
no
0.05 mg/kg
Details
226-029-0
5232-99-5
487
45640
yes
no
0.05 mg/kg
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
430-800-9
129228-21-3
763
39925
yes
yes
0.05 mg/kg
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
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
858
38565
yes
yes
0.05 mg/kg
SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer.
Details
ANOX 1315; ANOX BF; DURAD AX 38
413-750-2
171090-93-0
895
47060
yes
no
0.05 mg/kg
Only to be used in polyolefins in contact with foods other than fatty/ high-alcoholic and dairy products.
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
204-179-8
117-21-5
786
14627
no
no
0.05 mg/kg
SML expressed as 3-chlorophthalic acid.
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
216-245-3
1533-45-5
422
38515
yes
yes
0.05 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
201-250-5
80-09-1
154
13617
16090
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
240-759-7
16712-64-4
624
18897
no
no
0.05 mg/kg
Details
682-678-3
182121-12-6
779
39815
yes
yes
0.05 mg/kg
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
203-080-7
103-11-7
206
11500
no
no
0.05 mg/kg
Details
213-663-8
999-61-1
385
11530
no
no
0.05 mg/kg
SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester.
It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).
Details
681-637-7
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
Details
235-697-2
12542-30-2
605
11005
no
no
0.05 mg/kg
Details
218-463-4
2156-97-0
437
11245
no
no
0.05 mg/kg
Details
293-728-5
91082-17-6
884
34240
yes
no
0.05 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
-
-
343
23770
no
no
0.05 mg/kg
Details

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