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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 23 April 2024. Database contains 1080 unique substances/entries.

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Showing 251 - 300 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
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
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',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',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
myristic acid	208-875-2	544-63-8	348	67891 22350	yes	no			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
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
montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol	-	-	67	67840	yes	no			Details
montan wax Wax obtained by extraction of lignite.	232-313-5	8002-53-7	529	67850	yes	no			Details
monomethyltin tris(isooctyl mercaptoacetate)	259-374-0	54849-38-6	695	67520	yes	no			Details
monomethyltin tris(ethylhexyl mercaptoacetate)	260-828-5	57583-34-3	697	67515	yes	no			Details
mono-n-octyltin tris(isooctyl mercaptoacetate)	247-665-5	26401-86-5	645	67760	yes	no			Details
mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate)	-	-	66	67600	yes	no			Details
mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)	248-227-6	27107-89-7	657	67680	yes	no			Details
mono-n-dodecyltin tris(isooctyl mercaptoacetate)	266-836-5	67649-65-4	720	67360	yes	no			Details
molybdenum disulphide	215-263-9	1317-33-5	404	67200	yes	no			Details
mixture of methylbranched and linear C14-C18 alkanamides, derived from fatty acids	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
mixture of 4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene	-	-	65	67155	yes	no		Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation). Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %)	Details
mica	601-648-2	12001-26-2	597	67120	yes	no			Details
methylsilsesquioxane	614-610-5	68554-70-1	730	66930	yes	no		Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.	Details
methylhydroxypropylcellulose	618-389-6	9004-65-3	560	66700	yes	no			Details
methylhydroxymethylcellulose	-	-	64	66695	yes	no			Details
methylethylcellulose	-	9004-59-5	557	66640	yes	no			Details
methylcellulose	618-391-7	9004-67-5	561	66240	yes	no			Details
methylcarboxymethylcellulose	-	37206-01-2	683	66200	yes	no			Details
mannitol	201-770-2	87-78-5	162	65520	yes	no			Details
manganese pyrophosphite	-	-	63	65440	yes	no			Details
manganese oxide	234-378-5	11129-60-5	594	65360	yes	no			Details
manganese hypophosphite	233-143-4	10043-84-2	586	65280	yes	no			Details
manganese hydroxide	882-488-2	12626-88-9	606	65200	yes	no			Details
manganese chloride	231-869-6	7773-01-5	520	65120	yes	no			Details
malonic acid	205-503-0	141-82-2	328	65040	yes	no			Details
malic acid	230-022-8	6915-15-7	499	19965 65020	yes	no		In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.	Details
maleic anhydride-styrene, copolymer, sodium salt	607-789-6	25736-61-2	642	64990	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 0,05 % (w/w).	Details
maleic acid	203-742-5	110-16-7	248	19540 64800	yes	no			Details
magnesium oxide	215-171-9	1309-48-4	397	64720	yes	no			Details
magnesium hydroxide	215-170-3	1309-42-8	396	64640	yes	no			Details
lysine, salts	-	-	62	64500	yes	no			Details
lithium iodide	233-822-5	10377-51-2	588	64320	yes	no			Details
linolenic acid	217-792-0	28290-79-1	663	64150	yes	no			Details
linoleic acid	200-470-9	60-33-3	112	64015	yes	no			Details
lignosulphonic acid	617-129-9	8062-15-5	540	63940	yes	no	0.24 mg/kg	Only to be used as dispersant for plastics dispersions.	Details
lignoceric acid	209-180-7	557-59-5	350	63920	yes	no			Details
levulinic acid	204-649-2	123-76-2	299	63840	yes	no			Details
lecithin 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
lauric acid	205-582-1	143-07-7	330	63280 19470	yes	no			Details
lactic acid, butyl ester	205-316-4	138-22-7	322	63040	yes	no			Details
lactic acid	200-018-0	50-21-5	99	19460 62960	yes	no			Details
L-(+)-tartaric acid	201-766-0	87-69-4	161	92160	yes	no			Details
kaolin, calcined 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

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