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 11 June 2021. Database contains 1072 unique substances/entries.
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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
-
99880-64-5
754
56020
yes
no
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
202-804-9
99-96-7
190
18880
no
no
Details
202-785-7
99-76-3
189
60200
yes
no
Details
202-774-7
99-63-8
188
19180
no
no
Details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
Details
202-679-0
98-54-4
186
14020
no
no
0.05 mg/kg
Details
213-551-9
976-56-7
1007
no
no
Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET).
Details
202-617-2
97-90-5
185
20440
no
no
0.05 mg/kg
Details
202-615-1
97-88-1
184
20110
no
no
Details
202-613-0
97-86-9
183
21010
no
no
Details
202-599-6
97-65-4
182
19270
no
no
Details
202-597-5
97-63-2
181
20890
no
no
Details
202-589-1
97-53-0
180
17160
no
no
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
202-525-2
96-69-5
178
92800
yes
yes
0.48 mg/kg
Details
202-510-0
96-49-1
177
16955
no
no
30 mg/kg
SML expressed as ethyleneglycol.
Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.
Details
202-500-6
96-33-3
176
11710
no
no
Details
202-473-0
96-05-9
175
20050
no
no
0.05 mg/kg
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
202-423-8
95-48-7
174
14740
no
no
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
213-424-8
947-04-6
382
19490
no
no
5 mg/kg
Details
202-307-7
94-13-3
173
60240
yes
no
Details
700-485-5
939402-02-5
974
74050
yes
yes
10 mg/kg
SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.
Details
700-485-5
939402-02-5
974
74050
yes
yes
1 mg/kg
The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.
Details
213-245-5
931-88-4
381
15030
no
no
0.05 mg/kg
Only to be used in polymers contacting foods for which simulant A is laid down.
Details
202-284-3
93-89-0
172
37840
yes
no
Details
202-259-7
93-58-3
171
38080
yes
no
Details
The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.
296-473-8
92704-41-1
753
62800
yes
no
Details
213-120-5
925-60-0
380
11980
no
no
Details
213-103-2
924-42-5
379
21940
no
no
0.01 mg/kg
Details
213-086-1
923-02-4
378
21970
no
no
0.05 mg/kg
Details
202-200-5
92-88-6
170
16000
no
no
6 mg/kg
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
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
202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
202-095-6
91-76-9
168
15310
13075
no
no
5 mg/kg
Details
202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
700-323-3
908020-52-0
926
71955
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
Details
-
90751-07-8
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 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
618-565-2
9049-76-7
579
61800
yes
no
Details
618-558-4
9046-01-9
578
79600
yes
no
5 mg/kg
For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
Details
695-178-5
9044-17-1
577
62280
yes
no
Details
618-528-0
9032-42-2
576
60880
yes
no
Details
618-459-6
9010-88-2
868
53245
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
232-689-0
9006-04-6
574
24250
84560
yes
no
Details
618-424-5
9005-71-4
573
79440
yes
no
Details

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