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 24 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
13075
15310
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
618-422-4
9005-70-3
572
79360
yes
no
Details
1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
Details
618-421-9
9005-66-7
570
79200
yes
no
Details
1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
Details
1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
Details
618-414-0
9005-37-2
567
82080
yes
no
Details
232-680-1
9005-32-7
566
33350
yes
no
Details
618-410-9
9005-27-0
565
61120
yes
no
Details
High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.
232-679-6
9005-25-8
564
88800
24540
yes
no
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
618-392-2
9004-70-0
562
22450
no
no
Details
618-391-7
9004-67-5
561
66240
yes
no
Details
618-389-6
9004-65-3
560
66700
yes
no
Details
618-388-0
9004-64-2
559
61680
yes
no
Details
618-387-5
9004-62-0
558
60560
yes
no
Details
-
9004-59-5
557
66640
yes
no
Details
618-385-4
9004-58-4
556
54260
yes
no
Details
618-384-9
9004-57-3
555
53280
yes
no
Details
618-381-2
9004-36-8
554
43300
yes
no
Details
232-674-9
9004-34-6
553
14500
43280
yes
no
Details
618-363-4
9003-39-8
552
81500
yes
no
The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC [OJ L 253, 20.9.2008, p. 1.].
Details
618-355-0
9003-11-6
551
79920
yes
no
Details
618-352-4
9003-07-0
550
81060
yes
no
Details
618-339-3
9002-88-4
549
80000
yes
no
Details
A complex combination produced in mammary tissue from amino acids supplied by the blood. It contains several proteins, phosphorus, and calcium
232-555-1
9000-71-9
548
42800
yes
no
Details
A complex combination of proteins obtained by hydrolysis of collagen by boiling skin, tendons, ligaments, bones, etc.
232-554-6
9000-70-8
547
55440
yes
no
Details
232-553-0
9000-69-5
546
71440
yes
no
Details
232-552-5
9000-65-1
545
93680
yes
no
Details
232-536-8
9000-30-0
544
58400
yes
no
Details
Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Shorea, Dipterocarpaceae).
232-528-4
9000-16-2
543
45920
yes
no
Details
618-326-2
9000-11-7
542
42640
yes
no
Details
232-519-5
9000-01-5
541
58480
yes
no
Details
201-898-9
89-32-7
166
24057
no
no
0.05 mg/kg
Details
618-128-6
882073-43-0
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
201-873-2
88-99-3
165
23200
74480
yes
no
Details
201-873-2
88-99-3
192
23187
no
no
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
201-814-0
88-24-4
163
66400
yes
yes
Details
CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
402-950-5
87826-41-3
752
39890
yes
no
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
700-107-9
87189-25-1
751
81515
yes
no
Details
201-770-2
87-78-5
162
65520
yes
no
Details
201-766-0
87-69-4
161
92160
yes
no
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
212-782-2
868-77-9
374
21190
no
no
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
Details
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details

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