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 2019/1338/EU, 9 Aug 2019

Also referred to as the Plastics Implementation Measure (PIM), this Regulation provides the Union List of monomers and other substances authorized in the manufacture of food contact plastics.

Last updated 23 November 2020. Database contains 1069 unique substances/entries.
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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
19243
21640
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
23830
81882
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
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
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
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
48720
15970
yes
no
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
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
224-069-3
4191-73-5
478
60180
yes
no
Details
202-785-7
99-76-3
189
60200
yes
no
Details

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