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.

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Last updated 30 May 2023. Database contains 1067 unique substances/entries.
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Showing 951 - 1,000 of 1,067 results.
Substance Name
EC No.
CAS No.
FCM No
Ref No.
Additive or PPA
FRF applicable
SML (mg/kg)
Restriction(s)
 
2,3,6-trimethylphenol
219-330-3
2416-94-6
882
25872
no
no
0.05 mg/kg
Details
2,3,3,4,4,5,5-heptafluoro-1-pentene
-
1547-26-8
1063
no
no
Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
 Details
2,2-bis(hydroxymethyl)propionic acid
225-306-3
4767-03-7
484
13395
no
no
0.05 mg/kg
Details
2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride)
253-781-7
38103-06-9
687
13614
13530
no
no
0.05 mg/kg
Details
2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether
216-823-5
1675-54-3
426
13610
13510
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
 Details
2,2-bis(4-hydroxyphenyl)propane
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
2,2,4-trimethyl-1,3-pentanediol diisobutyrate
229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
 Details
2,2,4,4-tetramethylcyclobutane-1,3-diol
221-140-0
3010-96-6
881
25187
no
no
5 mg/kg
Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
 Details
2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer
-
78301-43-6
742
92700
yes
yes
5 mg/kg
Details
2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate
600-028-9
1001254-87-0
4
22332
no
no
1 mg/kg in final product expressed as isocyanate moiety.
 Details
2,2'-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]
274-572-7
70331-94-1
739
70000
yes
no
Details
2,2'-methylenebis(4-methyl-6-cyclohexylphenol)
223-773-8
4066-02-8
472
66560
yes
yes
Details
2,2'-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)
201-044-5
77-62-3
137
66580
yes
yes
Details
2,2'-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate
617-688-9
85209-93-4
750
66350
yes
no
5 mg/kg
Details
2,2'-methylene bis(4-methyl-6-tert-butylphenol)
204-327-1
119-47-1
285
66480
yes
yes
Details
2,2'-methylene bis(4-ethyl-6-tert-butylphenol)
201-814-0
88-24-4
163
66400
yes
yes
Details
2,2'-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite
403-020-1
118337-09-0
759
54300
yes
yes
6 mg/kg
Details
2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)
202-319-2
94-28-0
310
16390
22437
no
no
0.05 mg/kg
Details
2,2'-dihydroxy-5,5'-dichlorodiphenylmethane
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
2,2'-dihydroxy-4-methoxybenzophenone
205-026-8
131-53-3
317
48880
yes
yes
Details
2,2'-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one]
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
796
72141
yes
yes
0.05 mg/kg
SML including the sum of its hydrolysis products.
 Details
2,2',2'-nitrilo(triethyl tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite)
279-459-6
80410-33-9
745
68145
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
 Details
12-hydroxystearic acid
203-366-1
106-14-9
214
61840
yes
no
Details
12-aminododecanoic acid
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
11-aminoundecanoic acid
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
1-vinylimidazole
214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
Details
1-tetradecene
214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
Details
1-propanol
200-746-9
71-23-8
122
23800
no
no
Details
1-pentene
203-694-5
109-67-1
245
22900
no
no
5 mg/kg
Details
1-pentanol
200-752-1
71-41-0
124
22870
no
no
Details
1-octene
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
1-octanol
203-917-6
111-87-5
265
22600
no
no
Details
1-nonanol
205-583-7
143-08-8
331
22480
no
no
Details
1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane
223-861-6
4098-71-9
475
19110
no
no
1 mg/kg in final product expressed as isocyanate moiety.
 Details
1-hexene
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
Details
1-hexadecanol
253-149-0
36653-82-4
681
18310
no
no
Details
1-dodecene
203-968-4
112-41-4
375
15130
no
no
0.05 mg/kg
Details
1-dodecene
203-968-4
112-41-4
268
16704
no
no
0.05 mg/kg
Details
1-decanol
203-956-9
112-30-1
267
15100
no
no
Details
1-butene
203-449-2
106-98-9
222
13870
no
no
Details
1-butanol
200-751-6
71-36-3
123
13840
no
no
Details
1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
Details
1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride
223-805-0
4080-31-3
474
43600
yes
no
0.3 mg/kg
Details
1-(2-hydroxyethyl)pyrrolidin-2-one
222-359-4
3445-11-2
622
69840
yes
yes
5 mg/kg
Details
1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
1,9-decadiene
216-711-6
1647-16-1
424
15070
no
no
0.05 mg/kg
Details
1,7-octadiene
223-054-9
3710-30-3
1034
no
no
0.05 mg/kg
Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.
 Details
1,6-hexanediol
211-074-0
629-11-8
657
67680
yes
no
Details
1,6-hexanediamine, N1,N6-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymer with 2,4-dichloro-6-(4-morpholinyl)-1,3,5-triazine
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
1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
Details
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