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.

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Last updated 26 April 2024. Database contains 1080 unique substances/entries.
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Substance Name
EC No.
CAS No.
FCM No
Ref No.
Additive or PPA
FRF applicable
SML (mg/kg)
Restriction(s)
 
monomethyltin tris(isooctyl mercaptoacetate)
259-374-0
54849-38-6
695
67520
yes
no
Details
montan wax
Wax obtained by extraction of lignite.
232-313-5
8002-53-7
529
67850
yes
no
Details
montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
-
-
67
67840
yes
no
Details
montmorillonite clay modified by dimethyldialkyl (C16-C18)ammonium chloride
-
-
1030
yes
no
0.05 mg/kg
Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below.
The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food.
Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
 Details
Montmorillonite clay modified with hexadecyltrimethylammonium bromide
-
-
1075
yes
no
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
 Details
myristic acid
208-875-2
544-63-8
348
67891
22350
yes
no
Details
N,N',N'',N''-tetrakis(4,6-bis(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
791
92470
yes
no
0.05 mg/kg
Details
N,N',N''-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamide
481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N'-diformylhexamethylenediamine
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
795
40155
yes
no
0.05 mg/kg
Details
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