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 (EU) 2023/1627, OJ L 201, 11 August 2023

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 28 March 2024. Database contains 1080 unique substances/entries.
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241-234-5
17194-00-2
625
36720
yes
no
Details
233-020-5
10022-31-8
581
36800
yes
no
Details
-
12007-55-5
599
36840
yes
no
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
221-304-1
3061-75-4
458
36960
yes
no
Details
204-010-8
112-85-6
272
37040
yes
no
Details
A colloidal clay. Consists primarily of montmorillonite.
215-108-5
1302-78-9
393
37280
yes
no
Details
202-860-4
100-52-7
195
37360
yes
no
Details
200-618-2
65-85-0
116
37600
13090
yes
no
Details
205-252-7
136-60-7
320
37680
yes
no
Details
202-284-3
93-89-0
172
37840
yes
no
Details
202-259-7
93-58-3
171
38080
yes
no
Details
219-020-8
2315-68-6
441
38160
yes
no
Details
202-859-9
100-51-6
194
13150
no
no
Details
413-110-2
135861-56-2
766
38879
yes
no
Details
NC-4
406-176-9
79072-96-1
743
38950
yes
no
Details
-
69158-41-4
752
39890
yes
no
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
233-139-2
10043-35-3
584
40320
13620
yes
no
Details
233-136-6
10043-11-5
583
40400
yes
no
Details
203-448-7
106-97-8
221
40570
yes
no
Details
204-646-6
123-72-8
298
14110
no
no
Details
203-532-3
107-92-6
229
14140
no
no
Details
203-383-4
106-31-0
215
14170
no
no
Details
227-265-7
5743-36-2
489
41040
yes
no
Details
233-140-8
10043-52-4
585
41120
yes
no
Details
215-137-3
1305-62-0
394
41280
yes
no
Details
215-138-9
1305-78-8
395
41520
yes
no
Details
200-945-0
76-22-2
136
41680
yes
no
Details
The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.
232-347-0
8006-44-8
530
41760
yes
no
Details
203-313-2
105-60-2
212
41840
14200
yes
no
Details
218-336-3
2123-24-2
435
14230
no
no
Details
207-938-1
502-44-3
342
14260
no
no
Details
204-677-5
124-07-2
304
14320
41960
yes
no
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
215-609-9
1333-86-4
411
42080
yes
no
Primary particles of 10 - 300 nm which are aggregated to a size of 100 - 1200 nm which may form agglomerates within the size distribution of 300 nm - mm.
Toluene extractables: maximum 0,1 %, determined according to ISO method 6209.
UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis.
Benzo(a)pyrene content: max 0,25 mg/kg carbon black.
Maximum use level of carbon black in the polymer: 2,5 % w/w.
Details
204-696-9
124-38-9
307
42160
yes
no
Details
211-128-3
630-08-0
362
14350
no
no
Details
-
-
21
42500
yes
no
Details
618-326-2
9000-11-7
542
42640
yes
no
Details
The wax derived from Copernicia cerifera, Palmae.
232-399-4
8015-86-9
533
42720
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
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
264-705-7
64147-40-6
712
42960
yes
no
Details
-
-
22
43200
yes
no
Details
232-674-9
9004-34-6
553
43280
14500
yes
no
Details
618-381-2
9004-36-8
554
43300
yes
no
Details
The product obtained by treating cellulose with caustic soda, reacting this with carbon disulfide, dissolving this in a dilute alkali solution and extruding into an acid to form a continuous viscose tube.
270-493-7
68442-85-3
727
43360
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
264-846-4
64365-11-3
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
231-959-5
7782-50-5
522
14530
no
no
Details
-
10436-08-5
589
52645
yes
no
Details
201-069-1
77-92-9
139
44160
14680
yes
no
Details
201-070-7
77-93-0
140
44640
yes
no
Details
234-334-5
11104-61-3
593
44960
yes
no
Details
232-131-6
7787-70-4
523
45195
yes
no
Details
235-285-2
12158-74-6
972
45197
yes
no
Details
215-625-6
1335-23-5
412
45200
yes
no
Details
-
-
24
45280
yes
no
Details
238-455-4
14464-46-1
614
45560
yes
no
Details
223-077-4
3724-65-0
467
45600
14800
yes
no
Details
-
263244-54-8
885
45676
yes
no
Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.
Details
221-639-3
3173-53-3
460
14950
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
203-629-0
108-91-8
240
45760
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
611-185-8
54686-97-4
752
39890
yes
no
Details
281-837-0
84030-61-5
747
47600
yes
yes
Details
-
69226-46-6
30
50560
yes
no
Details
233-117-2
10039-33-5
582
50240
yes
no
Details
239-622-4
15571-58-1
619
50320
yes
no
Details
268-500-3
68109-88-6
29
50360
yes
no
Details
251-576-7
33568-99-9
676
50400
yes
no
Details
247-666-0
26401-97-8
646
50480
yes
no
Details
-
-
28
50160
yes
no
Details
222-883-3
3648-18-8
466
50640
yes
no
Details
239-625-0
15571-60-5
620
50720
yes
no
Details
-
-
31
50800
yes
no
Details
-
-
32
50880
yes
no
Details
260-414-4
56875-68-4
736
50960
yes
no
Details
239-581-2
15535-79-2
618
51040
yes
no
Details
-
-
33
51120
yes
no
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
272-489-0
68855-54-9
734
46380
yes
no
Details
251-136-4
32647-67-9
674
46480
yes
no
Details
-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
225-863-2
5124-30-1
485
15700
13560
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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) and poly(ethylene 2,5-furandicarboxylate) (PEF)
Details
203-872-2
111-46-6
263
47680
13326
15760
yes
no
Details
247-977-1
26761-40-0
729
75105
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
247-977-1
26761-40-0
729
75105
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
249-079-5
28553-12-0
728
75100
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
249-079-5
28553-12-0
728
75100
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
210-478-4
616-38-6
1067
no
no
Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
Details
200-664-3
67-68-5
120
49540
yes
no
Details
260-829-0
57583-35-4
698
49595
yes
no
Details
247-862-6
26636-01-1
650
49600
yes
no
Details
204-794-1
126-58-9
311
51200
16480
yes
no
Details
626-593-1
4128-73-8
476
16570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
227-534-9
5873-54-1
490
16600
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
202-966-0
101-68-8
198
16630
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details

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