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

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Showing 301 - 400 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-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids	-	-	1081		yes	no		Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III.	Details
N,N-bis(2-hydroxyethyl)dodecanamide	204-393-1	120-40-1	923	39150	yes	no	5 mg/kg	The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, shall not result in a migration of diethanolamine higher than 0,3 mg/kg food.	Details
N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides	-	-	20	39120	yes	no		SML(T) expressed excluding HCl.	Details
N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine	-	-	19	39090	yes	no			Details
N,N,N',N'-tetrakis(2-hydroxypropyl)ethylenediamine	203-041-4	102-60-3	204	92640 25180	yes	no			Details
N,N'-ethylenebisstearamide	203-755-6	110-30-5	250	53520	yes	no			Details
N,N'-ethylenebispalmitamide	226-864-0	5518-18-3	488	53440	yes	no			Details
N,N'-ethylenebisoleamide	203-756-1	110-31-6	251	53360	yes	no			Details
N,N'-divinyl-2-imidazolidinone	237-457-2	13811-50-2	612	16694	no	no	0.05 mg/kg		Details
N,N'-diphenylthiourea	203-004-2	102-08-9	200	51680	yes	yes	3 mg/kg		Details
N,N'-dicyclohexyl-2,6-naphthalene dicarboxamide	-	153250-52-3	772	47500	yes	no	5 mg/kg		Details
N,N'-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide	-	132459-54-2	764	13317	no	no	0.05 mg/kg	Purity > 98,1 % (w/w). Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).	Details
N,N'-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide	251-156-3	32687-78-8	675	38800	yes	yes	15 mg/kg		Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer	-	61269-61-2	701	40160	yes	no	2.4 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
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
mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate	915-277-1	32052-51-0	4	22332	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane	247-063-2	25513-64-8	641	22331	no	no	0.05 mg/kg		Details
mixture composed of 97 % tetraethyl orthosilicate (TEOS) with CAS No 78-10-4 and 3 % hexamethyldisilazane (HMDS) with CAS No 999-97-3	-	-	1062		no	no		Only to be used for the production of recycled PET and at up to 0,12 % (w/w).	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
methanol	200-659-6	67-56-1	117	21550	no	no			Details
methallylsulphonic acid, salts	-	-	818	21530	no	no	5 mg/kg		Details
methacrylonitrile	204-817-5	126-98-7	312	21490	no	no	0.01 mg/kg		Details
methacrylic anhydride	212-084-8	760-93-0	370	21460	no	no			Details
methacrylic acid, tert-butyl ester	209-548-7	585-07-9	355	20170	no	no			Details
methacrylic acid, sulphopropyl ester	-	54276-35-6	694	21400	no	no	0.05 mg/kg		Details
methacrylic acid, sec-butyl ester	221-073-7	2998-18-7	457	20140	no	no			Details
methacrylic acid, propyl ester	218-639-0	2210-28-8	440	21340	no	no			Details
methacrylic acid, phenyl ester	218-542-3	2177-70-0	439	21280	no	no			Details
methacrylic acid, monoester with ethyleneglycol	212-782-2	868-77-9	374	21190	no	no			Details
methacrylic acid, methyl ester	201-297-1	80-62-6	156	21130	no	no			Details
methacrylic acid, isopropyl ester	225-094-2	4655-34-9	482	21100	no	no			Details
methacrylic acid, isobutyl ester	202-613-0	97-86-9	183	21010	no	no			Details
methacrylic acid, ethyl ester	202-597-5	97-63-2	181	20890	no	no			Details
methacrylic acid, diester with ethyleneglycol	202-617-2	97-90-5	185	20440	no	no	0.05 mg/kg		Details
methacrylic acid, diester with 1,4-butanediol	218-218-1	2082-81-7	434	20410	no	no	0.05 mg/kg		Details
methacrylic acid, cyclohexyl ester	202-943-5	101-43-9	197	20260	no	no	0.05 mg/kg		Details
methacrylic acid, butyl ester	202-615-1	97-88-1	184	20110	no	no			Details
methacrylic acid, benzyl ester	219-674-4	2495-37-6	447	20080	no	no			Details
methacrylic acid, allyl ester	202-473-0	96-05-9	175	20050	no	no	0.05 mg/kg		Details
methacrylic acid, 2-sulphoethyl ester	234-207-4	10595-80-9	590	21370	no	no	0.01 mg/kg		Details
methacrylic acid, 2-(dimethylamino)-ethyl ester	220-688-8	2867-47-2	455	20530	no	no	0.01 mg/kg		Details
methacrylic acid, 2,3-epoxypropyl ester	203-441-9	106-91-2	220	20590	no	no	0.02 mg/kg		Details
methacrylic acid	201-204-4	79-41-4	150	20020	no	no			Details
methacrylamide	201-202-3	79-39-0	149	19990	no	no	0.01 mg/kg		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 anhydride	203-571-6	108-31-6	234	19960	no	no			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
m-cresol	203-577-9	108-39-4	235	14710	no	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
lignocellulose	234-384-8	11132-73-3	595	19510	no	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
laurolactam	213-424-8	947-04-6	382	19490	no	no	5 mg/kg		Details
lauric acid, vinyl ester	218-414-7	2146-71-6	436	19480	no	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
kaolin A clay that is essentially kaolinite, a hydrated aluminum silicate. It has a high fusion point and is the most refractory of all clays.	310-194-1	1332-58-7	410	62720	yes	no		Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi- layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.	Details
japan wax	-	8001-39-6	525	62640	yes	no			Details
itaconic acid	202-599-6	97-65-4	182	19270	no	no			Details

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