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

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Showing 701 - 800 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
isopentane	201-142-8	78-78-4	143	62450	yes	no			Details
japan wax	-	8001-39-6	525	62640	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
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
lactic acid, butyl ester	205-316-4	138-22-7	322	63040	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Lauric acid	-	-	330	63280 19470	yes	no			Details
lauric acid	205-582-1	143-07-7	330	63280 19470	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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Levulinic acid	-	-	299	63840	yes	no			Details
levulinic acid	204-649-2	123-76-2	299	63840	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Lignoceric acid	-	-	350	63920	yes	no			Details
lignoceric acid	209-180-7	557-59-5	350	63920	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Lignosulphonic acid	-	-	540	63940	yes	no	0.24 mg/kg	Only to be used as dispersant for plastics dispersions.	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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Linoleic acid	-	-	112	64015	yes	no			Details
linoleic acid	200-470-9	60-33-3	112	64015	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Linolenic acid	-	-	663	64150	yes	no			Details
linolenic acid	217-792-0	28290-79-1	663	64150	yes	no			Details
lithium iodide	233-822-5	10377-51-2	588	64320	yes	no			Details
lysine, salts	-	-	62	64500	yes	no			Details
magnesium hydroxide	215-170-3	1309-42-8	396	64640	yes	no			Details
magnesium oxide	215-171-9	1309-48-4	397	64720	yes	no			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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Malonic acid	-	-	328	65040	yes	no			Details
malonic acid	205-503-0	141-82-2	328	65040	yes	no			Details
manganese chloride	231-869-6	7773-01-5	520	65120	yes	no			Details
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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Mannitol	-	-	162	65520	yes	no			Details
mannitol	201-770-2	87-78-5	162	65520	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
methylcarboxymethylcellulose	-	37206-01-2	683	66200	yes	no			Details
methylcellulose	618-391-7	9004-67-5	561	66240	yes	no			Details
2,2'-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate	617-688-9	85209-93-4	750	66350	yes	no	5 mg/kg		Details
2,2'-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate	286-344-4	85209-91-2	749	66360	yes	yes	5 mg/kg		Details
2,2'-methylene bis(4-ethyl-6-tert-butylphenol)	201-814-0	88-24-4	163	66400	yes	yes			Details
2,2'-methylene bis(4-methyl-6-tert-butylphenol)	204-327-1	119-47-1	285	66480	yes	yes			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2'-Methylene bis(4-methyl-6-tert-butylphenol)	-	-	285	66480	yes	yes			Details
2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	223-773-8	4066-02-8	472	66560	yes	yes			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	-	-	472	66560	yes	yes			Details
2,2'-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	201-044-5	77-62-3	137	66580	yes	yes			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2'-Methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	-	-	137	66580	yes	yes			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
2-methyl-4-isothiazolin-3-one	220-239-6	2682-20-4	451	66755	yes	no	0.5 mg/kg	Only to be used in aqueous polymer dispersions and emulsions.	Details
(butyl acrylate, methyl methacrylate, styrene) copolymer	608-050-0	27136-15-8	869	66763	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.	Details
(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer	-	37953-21-2	857	66765	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.	Details
N-methylpyrrolidone	212-828-1	872-50-4	376	66905	yes	no	60 mg/kg		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
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
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
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-octyltin tris(isooctyl mercaptoacetate)	247-665-5	26401-86-5	645	67760	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
montan wax Wax obtained by extraction of lignite.	232-313-5	8002-53-7	529	67850	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Myristic acid	-	-	348	67891 22350	yes	no			Details
myristic acid	208-875-2	544-63-8	348	67891 22350	yes	no			Details
7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin	222-067-7	3333-62-8	465	68040	yes	no			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
2,2',2'-nitrilo(triethyl tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite)	279-459-6	80410-33-9	745	68145	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of n-Octylphosphonic acid	-	-	483	68860	yes	no	0.05 mg/kg		Details
n-octylphosphonic acid	225-218-5	4724-48-5	483	68860	yes	no	0.05 mg/kg		Details
oleamide	206-103-9	301-02-0	335	68960	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Oleyl alcohol	-	-	332	69760	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
2,2'-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	274-572-7	70331-94-1	739	70000	yes	no			Details
ozokerite	680-864-9	12198-93-5	602	70240	yes	no			Details
palmitic acid, butyl ester	203-829-8	111-06-8	258	70480	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Palmitoleic acid	-	-	338	71020	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 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
3H-perfluoro-3-[(3-methoxy-propoxy) propanoic acid], ammonium salt	-	958445-44-8	896	71958	yes	no		Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for 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[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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Perfluoro[2-(n-propoxy)propanoic acid]	-	-	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-(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
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
2,2'-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one] CYASORB(R) UV-3638 LIGHT STABILISER	418-280-1	18600-59-4	796	72141	yes	yes	0.05 mg/kg	SML including the sum of its hydrolysis products.	Details

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