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 14 June 2024. Database contains 1080 unique substances/entries.
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205-026-8
131-53-3
317
48880
yes
yes
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
403-020-1
118337-09-0
759
54300
yes
yes
6 mg/kg
Details
286-344-4
85209-91-2
749
66360
yes
yes
5 mg/kg
Details
201-814-0
88-24-4
163
66400
yes
yes
Details
204-327-1
119-47-1
285
66480
yes
yes
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details
201-044-5
77-62-3
137
66580
yes
yes
Details
223-773-8
4066-02-8
472
66560
yes
yes
Details
274-572-7
70331-94-1
739
70000
yes
no
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
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
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
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
-
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
203-615-4
108-78-1
239
25420
19975
93720
yes
no
2.5 mg/kg
Details
423-560-1
161717-32-4
774
95270
yes
yes
2 mg/kg
SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP.
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
412-440-4
2725-22-6
452
38885
yes
no
5 mg/kg
Details
438-600-3
110675-26-8
758
38940
yes
yes
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
CG 25-1320; IRGANOX 1520; TK 12229/1
402-860-6
110553-27-0
756
40020
yes
yes
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
205-029-4
131-56-6
318
48640
yes
no
Details
CG 27-145
411-220-5
134701-20-5
765
49485
yes
yes
1 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
230-426-4
7128-64-5
500
38560
yes
yes
0.6 mg/kg
Details
223-945-2
4130-42-1
477
46720
yes
yes
4.8 mg/kg
Details
204-881-4
128-37-0
315
46640
yes
no
3 mg/kg
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
223-445-4
3896-11-5
470
60400
yes
yes
Details
223-383-8
3864-99-1
469
60480
yes
yes
Details
219-470-5
2440-22-4
444
61440
yes
no
Details
CG 30-1577
411-380-6
147315-50-2
770
51700
yes
no
0.05 mg/kg
Details
257-624-3
52047-59-3
692
52320
yes
yes
0.06 mg/kg
Details
274-570-6
70321-86-7
738
60320
yes
yes
1.5 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
203-452-9
107-01-7
224
13900
no
no
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
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
203-234-3
104-76-7
209
17050
no
no
30 mg/kg
Details
205-031-5
131-57-7
319
61360
yes
yes
Details
-
3293-97-8
464
61280
yes
yes
Details
217-421-2
1843-05-6
431
61600
yes
yes
Details
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
220-239-6
2682-20-4
451
66755
yes
no
0.5 mg/kg
Only to be used in aqueous polymer dispersions and emulsions.
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
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
200-661-7
67-63-0
118
81882
23830
yes
no
Details
-
37486-69-4
903
yes
no
Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.
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
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
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
224-166-0
4221-80-1
480
46790
yes
no
Details
267-342-2
67845-93-6
721
46800
yes
no
Details
221-532-1
3135-18-0
459
46870
yes
no
Details
265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
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
236-946-8
13560-49-1
611
35120
yes
no
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
-
958445-44-8
896
71958
yes
no
Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.
Details
216-245-3
1533-45-5
422
38515
yes
yes
0.05 mg/kg
Details
235-841-4
13003-12-8
608
40800
yes
yes
6 mg/kg
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
210-288-1
611-99-4
359
15970
48720
yes
no
Details
202-200-5
92-88-6
170
16000
no
no
6 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
202-525-2
96-69-5
178
92800
yes
yes
0.48 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
245-818-0
23676-09-7
632
52880
yes
no
3.6 mg/kg
Details
204-399-4
120-47-8
287
60160
yes
no
Details

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