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 25 April 2024. Database contains 1080 unique substances/entries.
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1043
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
617-241-8
81541-12-0
752
39890
yes
no
Details
204-872-5
127-91-3
314
23500
no
no
Details
201-291-9
80-56-8
155
23470
no
no
Details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
Details
641-029-4
156065-00-8
874
16265
no
no
0.05 mg/kg
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
641-029-4
156065-00-8
874
16265
no
no
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
220-449-8
2768-02-7
453
26320
no
no
0.05 mg/kg
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
200-867-7
75-38-7
132
26140
no
no
5 mg/kg
Details
200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-315-5
57-13-6
107
25960
no
no
Details
246-466-0
24800-44-0
634
25910
no
no
Details
203-812-5
110-88-3
255
25900
no
no
5 mg/kg
Details
219-547-3
2459-10-1
971
25885
no
no
Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.
Details
209-008-0
552-30-7
349
25550
no
no
Details
208-432-3
528-44-9
347
25540
13050
no
no
Details
248-096-5
26896-48-0
655
25450
no
no
0.05 mg/kg
Details
203-048-2
102-70-5
205
25385
no
no
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.
Only to be used in hydrogels intended for non-direct food contact use.
Details
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-
5
25360
no
no
0.01 mg/kg
1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
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-
6
25380
no
no
0.05 mg/kg
Details
203-726-8
109-99-9
246
25150
no
no
0.6 mg/kg
Details
204-126-9
116-14-3
281
25120
no
no
0.05 mg/kg
Details
204-411-8
120-61-6
288
24970
no
no
Details
202-829-5
100-20-9
191
24940
no
no
Details
202-830-0
100-21-0
785
24910
no
no
Details
270-337-8
68425-17-2
724
24903
no
no
In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].
Details
200-334-9
57-50-1
108
24880
no
no
Details
203-570-0
108-30-5
233
24850
no
no
Details
248-104-7
26914-43-2
656
24760
no
no
0.05 mg/kg
Details
202-851-5
100-42-5
193
24610
no
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
215-211-5
1313-82-2
401
24475
no
no
Details
219-882-5
2561-88-8
450
24430
no
no
Details
203-845-5
111-20-6
260
24280
no
no
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
202-987-5
101-90-6
199
24073
no
no
0.01 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.
Details
201-898-9
89-32-7
166
24057
no
no
0.05 mg/kg
Details
200-879-2
75-56-9
135
24010
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
204-062-1
115-07-1
275
23980
no
no
Details
204-638-2
123-62-6
297
23950
no
no
Details
203-293-5
105-38-4
211
23920
no
no
Details
204-623-0
123-38-6
296
23860
no
no
Details
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147398-31-0
1059
no
no
The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000Da shall not exceed 5.0 mg/kg food.
Details
205-016-3
131-17-9
316
23230
no
no
0.01 mg/kg
Details
201-873-2
88-99-3
192
23187
no
no
Details
204-552-5
122-52-1
293
23175
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
258-053-2
52628-03-2
1082
no
no
0.05 mg/kg
Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.
Details

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