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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 29 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)
methacrylic acid	201-204-4	79-41-4	150	20020	no	no			Details
methacrylic acid, 2,3-epoxypropyl ester	203-441-9	106-91-2	220	20590	no	no	0.02 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-sulphoethyl ester	234-207-4	10595-80-9	590	21370	no	no	0.01 mg/kg		Details
methacrylic acid, allyl ester	202-473-0	96-05-9	175	20050	no	no	0.05 mg/kg		Details
methacrylic acid, benzyl ester	219-674-4	2495-37-6	447	20080	no	no			Details
methacrylic acid, butyl ester	202-615-1	97-88-1	184	20110	no	no			Details
methacrylic acid, cyclohexyl ester	202-943-5	101-43-9	197	20260	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, diester with ethyleneglycol	202-617-2	97-90-5	185	20440	no	no	0.05 mg/kg		Details
methacrylic acid, ethyl ester	202-597-5	97-63-2	181	20890	no	no			Details
methacrylic acid, isobutyl ester	202-613-0	97-86-9	183	21010	no	no			Details
methacrylic acid, isopropyl ester	225-094-2	4655-34-9	482	21100	no	no			Details
methacrylic acid, methyl ester	201-297-1	80-62-6	156	21130	no	no			Details
methacrylic acid, monoester with ethyleneglycol	212-782-2	868-77-9	374	21190	no	no			Details
methacrylic acid, phenyl ester	218-542-3	2177-70-0	439	21280	no	no			Details
methacrylic acid, propyl ester	218-639-0	2210-28-8	440	21340	no	no			Details
methacrylic acid, sec-butyl ester	221-073-7	2998-18-7	457	20140	no	no			Details
methacrylic acid, sulphopropyl ester	-	54276-35-6	694	21400	no	no	0.05 mg/kg		Details
methacrylic acid, tert-butyl ester	209-548-7	585-07-9	355	20170	no	no			Details
methacrylic anhydride	212-084-8	760-93-0	370	21460	no	no			Details
methacrylonitrile	204-817-5	126-98-7	312	21490	no	no	0.01 mg/kg		Details
methallylsulphonic acid, salts	-	-	818	21530	no	no	5 mg/kg		Details
methanol	200-659-6	67-56-1	117	21550	no	no			Details
methylcarboxymethylcellulose	-	37206-01-2	683	66200	yes	no			Details
methylcellulose	618-391-7	9004-67-5	561	66240	yes	no			Details
methylethylcellulose	-	9004-59-5	557	66640	yes	no			Details
methylhydroxymethylcellulose	-	-	64	66695	yes	no			Details
methylhydroxypropylcellulose	618-389-6	9004-65-3	560	66700	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
mica	601-648-2	12001-26-2	597	67120	yes	no			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
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 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 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 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
molybdenum disulphide	215-263-9	1317-33-5	404	67200	yes	no			Details
mono-n-dodecyltin tris(isooctyl mercaptoacetate)	266-836-5	67649-65-4	720	67360	yes	no			Details
mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)	248-227-6	27107-89-7	657	67680	yes	no			Details
mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate)	-	-	66	67600	yes	no			Details
mono-n-octyltin tris(isooctyl mercaptoacetate)	247-665-5	26401-86-5	645	67760	yes	no			Details
monomethyltin tris(ethylhexyl mercaptoacetate)	260-828-5	57583-34-3	697	67515	yes	no			Details
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

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