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

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Showing 201 - 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)
perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt	682-238-0	1190931-27-1	1045		yes	no		Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.	Details
perfluorooctanoic acid, ammonium salt	223-320-4	3825-26-1	468	71960	yes	no		Only to be used in repeated use articles, sintered at high temperatures.	Details
perfluoro[2-(poly(n-propoxy))propanoic acid]	680-272-0	51798-33-5	860	71980	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.	Details
perfluoro[2-(n-propoxy)propanoic acid]	236-236-8	13252-13-6	861	71990	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.	Details
perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt	700-323-3	908020-52-0	926	71955	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.	Details
perfluoro acetic acid, α-substituted with the copolymer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groups	682-234-9	329238-24-6	854	71943	yes	no		Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles.	Details
perchloric acid, salts	-	-	822	71938	yes	no			Details
Perchlorate	623-712-9	14797-73-0	822	71938	yes	no			Details
pentane	203-692-4	109-66-0	244	71720	yes	no			Details
pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	229-722-6	6683-19-8	496	71680	yes	no			Details
pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)	429-160-3	178671-58-4	778	71670	yes	yes	0.05 mg/kg		Details
pentaerythritol dioleate	246-665-2	25151-96-6	637	71635	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
pentaerythritol	204-104-9	115-77-5	279	22840 71600	yes	no			Details
pectin	232-553-0	9000-69-5	546	71440	yes	no			Details
palmitoleic acid	206-765-9	373-49-9	338	71020	yes	no			Details
palmitic acid, butyl ester	203-829-8	111-06-8	258	70480	yes	no			Details
palmitic acid	200-312-9	57-10-3	105	22780 70400	yes	no			Details
p-cresol-dicyclopentadiene-isobutylene, copolymer	271-867-2	68610-51-5	732	45450	yes	yes	5 mg/kg		Details
ozokerite	680-864-9	12198-93-5	602	70240	yes	no			Details
Oxirane, 2-methyl-, polymer with oxirane	618-355-0	9003-11-6	551	79920	yes	no			Details
oxalic acid	205-634-3	144-62-7	333	22775 69920	yes	no	6 mg/kg		Details
oleylpalmitamide	240-367-6	16260-09-6	622	69840	yes	yes	5 mg/kg		Details
oleyl alcohol	205-597-3	143-28-2	332	69760	yes	no			Details
oleic acid	204-007-1	112-80-1	270	22763 69040	yes	no			Details
oleamide	206-103-9	301-02-0	335	68960	yes	no			Details
octadecylerucamide	233-226-5	10094-45-8	587	68400	yes	yes	5 mg/kg		Details
octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate	218-216-0	2082-79-3	433	68320	yes	yes	6 mg/kg		Details
nepheline syenite	609-369-8	37244-96-5	684	68125	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
neodecanoic acid, salts	248-093-9	26896-20-8	819	68110	yes	no	0.05 mg/kg	Not to be used in polymers contacting fatty foods. Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. SML expressed as neodecanoic acid.	Details
n-octylphosphonic acid	225-218-5	4724-48-5	483	68860	yes	no	0.05 mg/kg		Details
N-methylpyrrolidone	212-828-1	872-50-4	376	66905	yes	no	60 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
n-decanoic acid	206-376-4	334-48-5	336	45940 15095	yes	no			Details
n-alkyl(C10-C13)benzenesulphonic acid	-	-	14	33801	yes	no	30 mg/kg		Details
N-(2-aminoethyl)ethanolamine	203-867-5	111-41-1	262	35284	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. For indirect food contact only, behind a PET layer.	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,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'-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(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
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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