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

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Showing 801 - 900 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
manganese hydroxide	882-488-2	12626-88-9	606	65200	yes	no			Details
manganese hypophosphite	233-143-4	10043-84-2	586	65280	yes	no			Details
manganese oxide	234-378-5	11129-60-5	594	65360	yes	no			Details
manganese pyrophosphite	-	-	63	65440	yes	no			Details
mannitol	201-770-2	87-78-5	162	65520	yes	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 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
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'-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-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer	-	61269-61-2	701	40160	yes	no	2.4 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'-dicyclohexyl-2,6-naphthalene dicarboxamide	-	153250-52-3	772	47500	yes	no	5 mg/kg		Details
N,N'-diphenylthiourea	203-004-2	102-08-9	200	51680	yes	yes	3 mg/kg		Details
N,N'-ethylenebisoleamide	203-756-1	110-31-6	251	53360	yes	no			Details
N,N'-ethylenebispalmitamide	226-864-0	5518-18-3	488	53440	yes	no			Details
N,N'-ethylenebisstearamide	203-755-6	110-30-5	250	53520	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-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)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)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-(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-alkyl(C10-C13)benzenesulphonic acid	-	-	14	33801	yes	no	30 mg/kg		Details
n-decanoic acid	206-376-4	334-48-5	336	45940 15095	yes	no			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-methylpyrrolidone	212-828-1	872-50-4	376	66905	yes	no	60 mg/kg		Details
n-octylphosphonic acid	225-218-5	4724-48-5	483	68860	yes	no	0.05 mg/kg		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
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
nepheline syenite	609-369-8	37244-96-5	684	68125	yes	no			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
octadecylerucamide	233-226-5	10094-45-8	587	68400	yes	yes	5 mg/kg		Details
oleamide	206-103-9	301-02-0	335	68960	yes	no			Details
oleic acid	204-007-1	112-80-1	270	22763 69040	yes	no			Details
oleyl alcohol	205-597-3	143-28-2	332	69760	yes	no			Details
oleylpalmitamide	240-367-6	16260-09-6	622	69840	yes	yes	5 mg/kg		Details
oxalic acid	205-634-3	144-62-7	333	22775 69920	yes	no	6 mg/kg		Details
Oxirane, 2-methyl-, polymer with oxirane	618-355-0	9003-11-6	551	79920	yes	no			Details
ozokerite	680-864-9	12198-93-5	602	70240	yes	no			Details
p-cresol-dicyclopentadiene-isobutylene, copolymer	271-867-2	68610-51-5	732	45450	yes	yes	5 mg/kg		Details
palmitic acid	200-312-9	57-10-3	105	22780 70400	yes	no			Details
palmitic acid, butyl ester	203-829-8	111-06-8	258	70480	yes	no			Details
palmitoleic acid	206-765-9	373-49-9	338	71020	yes	no			Details
pectin	232-553-0	9000-69-5	546	71440	yes	no			Details
pentaerythritol	204-104-9	115-77-5	279	22840 71600	yes	no			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 tetrakis (2-cyano-3,3-diphenylacrylate)	429-160-3	178671-58-4	778	71670	yes	yes	0.05 mg/kg		Details
pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	229-722-6	6683-19-8	496	71680	yes	no			Details
pentane	203-692-4	109-66-0	244	71720	yes	no			Details
Perchlorate	623-712-9	14797-73-0	822	71938	yes	no			Details
perchloric acid, salts	-	-	822	71938	yes	no			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
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[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-(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
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{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
petroleum hydrocarbon resins (hydrogenated)	-	-	97	72081/10	yes	no		Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing. Properties: Viscosity at 120 °C: > 3 Pa.s,Softening point: > 95 °C as determined by ASTM Method E 28-67,Bromine number: < 40 (ASTM D1159),The colour of a 50 % solution in toluene < 11 on the Gardner scale,Residual aromatic monomer ≤ 50 ppm.	Details
phosphoric acid	231-633-2	7664-38-2	509	23170 72640	yes	no			Details
phosphoric acid, diphenyl 2-ethylhexyl ester	214-987-2	1241-94-7	392	72800	yes	yes	2.4 mg/kg		Details
phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters	-	-	68	73160	yes	yes	0.05 mg/kg		Details
phosphoric acid, trichloroethyl ester	204-118-5	115-96-8	280	73720	yes	no	0.01 mg/kg		Details
phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester IRGAFOS 38	416-140-4	145650-60-8	769	74010	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	10 mg/kg	SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.	Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	1 mg/kg	The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.	Details
Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly [oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters	843-672-8	1227937-46-3	1076		yes	no	0.05 mg/kg	Only to be used (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.	Details
phosphorous acid, tris(2,4-di-tert-butylphenyl)ester	250-709-6	31570-04-4	671	74240	yes	no			Details
phosphorous acid, tris(nonyl-and/or dinonylphenyl) ester	-	-	69	74400	yes	yes	30 mg/kg		Details
phthalic acid	201-873-2	88-99-3	165	23200 74480	yes	no			Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no	6 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no	0.6 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details

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