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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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Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
ethylhydroxypropylcellulose	-	-	35	54280	yes	no			Details
fats and oils, from animal or vegetable food sources	-	-	36	54450	yes	no			Details
fats and oils, hydrogenated, from animal or vegetable food sources	-	-	37	54480	yes	no			Details
fatty acids, C16-18 saturated, esters with dipentaerythritol	-	-	1053		yes	no		Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.	Details
gadoleic acid	-	29204-02-2	667	55190	yes	no			Details
glass fibers	-	-	38	55520	yes	no			Details
glycerol dibehenate	-	99880-64-5	754	56020	yes	no			Details
glycerol monohexanoate	-	26402-23-3	647	56720	yes	no			Details
glycerol monooleate, ester with ascorbic acid	-	-	54	57040	yes	no			Details
glycerol monooleate, ester with citric acid	-	-	55	57120	yes	no			Details
glycerol monopalmitate, ester with ascorbic acid	-	-	56	57200	yes	no			Details
glycerol monopalmitate, ester with citric acid	-	-	57	57280	yes	no			Details
glycerol monostearate, ester with ascorbic acid	-	-	58	57600	yes	no			Details
glycerol monostearate, ester with citric acid	-	-	59	57680	yes	no			Details
glycerol, esters with 12-hydroxystearic acid	-	-	44	56495	yes	no			Details
glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated, linear, with an even number of carbon atoms (C16-C18)	-	-	41	56486	yes	no			Details
glycerol, esters with butyric acid	-	-	42	56487	yes	no			Details
glycerol, esters with erucic acid	-	-	43	56490	yes	no			Details
glycerol, esters with lauric acid	-	-	45	56500	yes	no			Details
glycerol, esters with linoleic acid	-	-	46	56510	yes	no			Details
glycerol, esters with nonanoic acid	-	-	48	56535	yes	no			Details
glycerol, esters with propionic acid	-	-	51	56570	yes	no			Details
glycine, salts	-	-	60	58300	yes	no			Details
ground sunflower seed hulls	-	-	1060		yes	no		Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E. The seed hulls shall be obtained from sunflower seeds that are fit for human consumption. The processing temperature of the plastic containing the additive shall not exceed 240 °C.	Details
hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440-12000)	-	-	789	60027	yes	no		Average molecular weight not less than 440 Da. Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).	Details
japan wax	-	8001-39-6	525	62640	yes	no			Details
lysine, salts	-	-	62	64500	yes	no			Details
manganese pyrophosphite	-	-	63	65440	yes	no			Details
methacrylic acid, sulphopropyl ester	-	54276-35-6	694	21400	no	no	0.05 mg/kg		Details
methallylsulphonic acid, salts	-	-	818	21530	no	no	5 mg/kg		Details
methylcarboxymethylcellulose	-	37206-01-2	683	66200	yes	no			Details
methylethylcellulose	-	9004-59-5	557	66640	yes	no			Details
methylhydroxymethylcellulose	-	-	64	66695	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 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
mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate)	-	-	66	67600	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
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[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'-dicyclohexyl-2,6-naphthalene dicarboxamide	-	153250-52-3	772	47500	yes	no	5 mg/kg		Details
N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine	-	-	19	39090	yes	no			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)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-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione	-	852282-89-4	809	49080	yes	yes	0.05 mg/kg	Only for use in PET.	Details
n-alkyl(C10-C13)benzenesulphonic acid	-	-	14	33801	yes	no	30 mg/kg		Details
N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers	-	66822-60-4	719	65920	yes	no			Details
neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid	-	-	810	68119	yes	no	5 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid	-	-	810	68119	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details

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