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 27 January 2022. Database contains 1072 unique substances/entries.
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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.
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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.
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236-946-8
13560-49-1
611
35120
yes
no
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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.
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265-512-0
65140-91-2
715
46880
yes
no
6 mg/kg
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221-532-1
3135-18-0
459
46870
yes
no
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267-342-2
67845-93-6
721
46800
yes
no
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224-166-0
4221-80-1
480
46790
yes
no
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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.
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430-800-9
129228-21-3
763
39925
yes
yes
0.05 mg/kg
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256-318-7
47465-97-4
691
13600
no
no
1.8 mg/kg
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202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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229-962-1
6864-37-5
498
16210
no
no
0.05 mg/kg
Only to be used in polyamides.
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-
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.
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-
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.
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200-661-7
67-63-0
118
23830
81882
yes
no
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213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
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220-239-6
2682-20-4
451
66755
yes
no
0.5 mg/kg
Only to be used in aqueous polymer dispersions and emulsions.
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201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
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217-421-2
1843-05-6
431
61600
yes
yes
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-
3293-97-8
464
61280
yes
yes
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205-031-5
131-57-7
319
61360
yes
yes
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203-234-3
104-76-7
209
17050
no
no
30 mg/kg
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245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
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226-029-0
5232-99-5
487
45640
yes
no
0.05 mg/kg
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228-250-8
6197-30-4
492
45650
yes
no
0.05 mg/kg
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203-452-9
107-01-7
224
13900
no
no
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205-483-3
141-43-5
326
12763
35170
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.
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201-851-2
88-68-6
164
34895
yes
no
0.05 mg/kg
Only for use in PET for water and beverages.
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239-268-0
15214-89-8
617
10660
no
no
0.05 mg/kg
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274-570-6
70321-86-7
738
60320
yes
yes
1.5 mg/kg
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257-624-3
52047-59-3
692
52320
yes
yes
0.06 mg/kg
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CG 30-1577
411-380-6
147315-50-2
770
51700
yes
no
0.05 mg/kg
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219-470-5
2440-22-4
444
61440
yes
no
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223-383-8
3864-99-1
469
60480
yes
yes
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223-445-4
3896-11-5
470
60400
yes
yes
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202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
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214-527-0
1141-38-4
389
22360
no
no
5 mg/kg
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209-400-1
576-26-1
352
16360
no
no
0.05 mg/kg
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204-881-4
128-37-0
315
46640
yes
no
3 mg/kg
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223-945-2
4130-42-1
477
46720
yes
yes
4.8 mg/kg
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230-426-4
7128-64-5
500
38560
yes
yes
0.6 mg/kg
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247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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411-220-5
134701-20-5
765
49485
yes
yes
1 mg/kg
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205-029-4
131-56-6
318
48640
yes
no
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202-095-6
91-76-9
168
15310
13075
no
no
5 mg/kg
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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.
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CG 25-1320; IRGANOX 1520; TK 12229/1
402-860-6
110553-27-0
756
40020
yes
yes
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