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 12 August 2022. 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
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
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
84560
24250
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
24540
88800
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
43280
14500
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
611-024-1
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
192
23187
no
no
Details
201-873-2
88-99-3
165
23200
74480
yes
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
286-344-4
85209-91-2
749
66360
yes
yes
5 mg/kg
Details
201-622-7
85-68-7
159
74560
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
201-622-7
85-68-7
159
74560
yes
no
30 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
201-607-5
85-44-9
158
23380
76320
yes
no
Details
282-811-1
84434-12-8
748
12765
no
no
0.05 mg/kg
Details
281-837-0
84030-61-5
747
47600
yes
yes
Details
212-661-4
840-65-3
373
22390
no
no
0.05 mg/kg
Details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
0.3 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
617-335-9
82451-48-7
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
212-485-8
822-06-0
372
18640
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
212-454-9
818-61-1
371
11830
11510
no
no
Details
617-241-8
81541-12-0
752
39890
yes
no
Details
ADK STAB PEP-36
410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
617-129-9
8062-15-5
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
539
24160
no
no
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
232-482-5
8050-31-5
538
84000
yes
no
Details
232-479-9
8050-26-8
537
84080
yes
no
Details
232-476-2
8050-15-5
536
84320
yes
no
Details
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
535
24100
24190
83840
24130
yes
no
Details
279-459-6
80410-33-9
745
68145
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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
232-417-0
8017-16-1
534
80720
yes
no
Details
The wax derived from Copernicia cerifera, Palmae.
232-399-4
8015-86-9
533
42720
yes
no
Details
232-391-0
8013-07-8
532
88640
yes
no
Details
232-391-0
8013-07-8
532
88640
yes
no
30 mg/kg
In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.
Details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
The wax obtained from the honeycomb of the bee. It consists primarily of myricyl palmitate, cerotic acid and esters and some high-carbon paraffins.
232-383-7
8012-89-3
531
36880
yes
no
Details
The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.
232-347-0
8006-44-8
530
41760
yes
no
Details
Wax obtained by extraction of lignite.
232-313-5
8002-53-7
529
67850
yes
no
Details
The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.
232-307-2
8002-43-5
528
63760
yes
no
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic. (Ricinus communis, Euphorbiaceae).
232-293-8
8001-79-4
527
42880
14411
yes
no
Details
A complex combination of hydrocarbons produced by the purification of ozocerite with sulfuric acid and filtration through bone black to form waxy cakes.
232-290-1
8001-75-0
526
43440
yes
no
Details
-
8001-39-6
525
62640
yes
no
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).
232-274-4
8001-22-7
524
24520
no
no
Details
201-297-1
80-62-6
156
21130
no
no
Details
201-291-9
80-56-8
155
23470
no
no
Details
201-250-5
80-09-1
154
13617
16090
no
no
0.05 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
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
NC-4
406-176-9
79072-96-1
743
38950
yes
no
Details
201-204-4
79-41-4
150
20020
no
no
Details
201-202-3
79-39-0
149
19990
no
no
0.01 mg/kg
Details
201-201-8
79-38-9
148
14650
no
no
0.01 mg/kg
Details
201-180-5
79-14-1
794
18117
no
no
Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.
Details
201-177-9
79-10-7
147
10690
no
no
Details
201-176-3
79-09-4
146
82000
23890
yes
no
Details
201-173-7
79-06-1
145
10630
no
no
0.01 mg/kg
Details
-
78301-43-6
742
92700
yes
yes
5 mg/kg
Details
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
201-142-8
78-78-4
143
62450
yes
no
Details
201-081-7
78-08-0
142
26305
no
no
0.05 mg/kg
Only to be used as a surface treatment agent.
Details
232-131-6
7787-70-4
523
45195
yes
no
Details
231-959-5
7782-50-5
522
14530
no
no
Details
231-955-3
7782-42-5
521
58320
yes
no
Details
231-869-6
7773-01-5
520
65120
yes
no
Details
231-867-5
7772-98-7
519
87120
yes
no
Details
-
7771-44-0
518
35845
yes
no
Details
231-830-3
7758-02-3
517
81520
yes
no
Details
231-821-4
7757-83-7
516
86960
yes
no
Details
231-791-2
7732-18-5
515
95855
26360
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
Details
231-722-6
7704-34-9
514
91840
yes
no
Details
201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
Details
201-070-7
77-93-0
140
44640
yes
no
Details
201-069-1
77-92-9
139
44160
14680
yes
no
Details
201-067-0
77-90-7
138
93760
yes
no
Details
201-044-5
77-62-3
137
66580
yes
yes
Details
257-757-7
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
231-679-3
7681-82-5
513
86800
yes
no
Details
231-659-4
7681-11-0
512
81680
yes
no
Details
231-639-5
7664-93-9
511
91920
yes
no
Details
231-635-3
7664-41-7
510
12789
35320
yes
no
Details
231-633-2
7664-38-2
509
23170
72640
yes
no
Details
231-599-9
7647-15-6
508
86560
yes
no
Details
231-595-7
7647-01-0
507
59990
yes
no
Details
231-555-9
7632-00-0
506
86920
yes
no
0.6 mg/kg
Details
231-548-0
7631-90-5
505
86480
yes
no
Details
231-545-4
7631-86-9
504
86240
yes
no
For synthetic amorphous silicon dioxide: primary particles of 1 - 100 nm which are aggregated to a size of 0,1 - 1 µm which may form agglomerates within the size distribution of 0,3 µm to the mm size.
Details
212-084-8
760-93-0
370
21460
no
no
Details
200-945-0
76-22-2
136
41680
yes
no
Details
231-493-2
7585-39-9
503
46080
yes
no
Details
200-879-2
75-56-9
135
24010
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-871-9
75-45-6
134
43680
yes
no
6 mg/kg
Content of chlorofluoromethane less than 1 mg/kg of the substance.
Details
200-870-3
75-44-5
133
23155
14380
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-867-7
75-38-7
132
26140
no
no
5 mg/kg
Details
200-866-1
75-37-6
131
48460
yes
no
Details
200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
Details
200-857-2
75-28-5
1069
yes
no
Only to be used as a blowing agent.
Details
200-849-9
75-21-8
129
17020
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-836-8
75-07-0
128
10060
no
no
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
431-850-4
7456-68-0
502
22778
no
no
0.05 mg/kg
Details
231-153-3
7440-44-0
713
43480
yes
no
Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).
Details
200-816-9
74-86-2
126
10210
no
no
Details
200-815-3
74-85-1
125
16950
no
no
Details
451-530-8
736150-63-3
783
55910
yes
no
Details
277-299-1
73138-82-6
741
83610
24070
yes
no
Details
843-673-3
73018-26-5
797
76807
yes
yes
Details

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