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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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Showing 1,001 - 1,080 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Acrylic acid	-	-	147	10690	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Acetic acid	-	-	115	30000 10090	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 Abietic acid	-	-	346	10030	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 4-tert-Butylphenol	-	-	186	14020	no	no	0.05 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 4-Cumylphenol	-	-	358	14841	no	no	0.05 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 4,4'-Thiobis(6-tert-butyl-3-methylphenol)	-	-	178	92800	yes	yes	0.48 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 3-Buten-2-ol	-	-	357	13932	no	no	0.01 mg/kg	Only to be used as a co-monomer for the preparation of polymeric additive.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2-Propanol	-	-	118	81882 23830	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 2-Ethyl-1-hexanol	-	-	209	17050	no	no	30 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 2-Aminoethanol	-	-	326	35170 12763	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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2-Acrylamido-2-methylpropanesulphonic acid	-	-	617	10660	no	no	0.05 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 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol	-	-	770	51700	yes	no	0.05 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 2,6-Naphthalenedicarboxylic acid	-	-	389	22360	no	no	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 2,6-Dimethylphenol	-	-	352	16360	no	no	0.05 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 2,6-Di-tert-butyl-p-cresol	-	-	315	46640	yes	no	3 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 2,6-Di-tert-butyl-4-ethylphenol	-	-	477	46720	yes	yes	4.8 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 2,4-Dimethyl-6-(1-methylpentadecyl)phenol	-	-	765	49485	yes	yes	1 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 2,4-Bis(octylthiomethyl)-6-methylphenol	-	-	756	40020	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 2,4-Bis(dodecylthiomethyl)-6-methylphenol	-	-	758	38940	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 2,3,6-Trimethylphenol	-	-	882	25872	no	no	0.05 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 2,2-Bis(hydroxymethyl)propionic acid	-	-	484	13395	no	no	0.05 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 2,2,4,4-Tetramethylcyclobutane-1,3-diol	-	-	881	25187	no	no	5 mg/kg	Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.	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
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
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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 12-Hydroxystearic acid	-	-	214	61840	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 12-Aminododecanoic acid	-	-	369	12761	no	no	0.05 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 11-Aminoundecanoic acid	-	-	443	12788	no	no	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 1-Propanol	-	-	122	23800	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Pentanol	-	-	124	22870	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Octanol	-	-	265	22600	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Nonanol	-	-	331	22480	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Hexadecanol	-	-	681	18310	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Decanol	-	-	267	15100	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Butanol	-	-	123	13840	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,6-Hexanediol	-	-	361	18700	no	no	0.05 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 1,4:3,6-Dianhydrosorbitol	-	-	364	15404	no	no	5 mg/kg	Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,4-Cyclohexanedicarboxylic acid	-	-	806	14876	no	no	5 mg/kg	Only to be used for manufacture of polyesters.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,3-Propanediol	-	-	343	23770	no	no	0.05 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 1,2-Propanediol	-	-	109	23740 81840	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 1,1,1-Tris(4-hydroxyphenol)ethane	-	-	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of (1,3:2,4) diparamethyldibenylidene sorbitol	-	-	752	39890	yes	no			Details
alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines	-	-	15	34130	yes	yes	30 mg/kg		Details
alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms	-	-	17	34281	yes	no			Details
alkyl(C8-C22)sulphonic acids	-	-	16	34230	yes	no	6 mg/kg		Details
alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)	-	-	13	33120	yes	no			Details
alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)	-	-	3	12375	no	no			Details
albumin, coagulated by formaldehyde	-	-	2	12340	no	no			Details
albumin	-	266309-43-7	1	12310	no	no			Details
acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters	-	174254-23-0	777	31542	yes	no		0,5 % in final product.	Details
acids, fatty, from animal or vegetable food fats and oils	-	-	12	31328	yes	no			Details
acids, fatty (C8-C22), esters with pentaerythritol	-	-	880	31348	yes	no			Details
acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22)	-	-	878	31335	yes	no			Details
acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22)	-	-	879	31336	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters	-	-	10	30612	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt	-	-	801	30607	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included)	-	-	9	30610	yes	no			Details
acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol	-	-	11	30960	yes	no			Details
acetylated mono- and diglycerides of fatty acids	-	-	8	30401	yes	no			Details
acetylacetic acid, salts	-	-	7	30370	yes	no			Details
9,10-dihydroxy stearic acid, oligomers	-	-	27	48960	yes	no	5 mg/kg		Details
5-sulphoisophthalic acid, salts	-	-	823	24889	no	no	5 mg/kg		Details
5,7-di-tert-butyl-3-(3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100 % w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20 % w/w)	-	-	26	46700	yes	no	5 mg/kg		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
3,3',5,5'-tetrakis(tert-butyl)-2,2'-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid	-	203255-81-6	792	92475	yes	yes	5 mg/kg	SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products.	Details
2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]	-	37486-69-4	903		yes	no		Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.	Details
2-hydroxy-4-n-hexyloxybenzophenone	-	3293-97-8	464	61280	yes	yes			Details
2,3,3,4,4,5,5-heptafluoro-1-pentene	-	1547-26-8	1063		no	no		Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.	Details
2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer	-	78301-43-6	742	92700	yes	yes	5 mg/kg		Details
1,3,5-tris(4-benzoylphenyl) benzene	-	227099-60-7	781	95265	yes	no	0.05 mg/kg		Details
1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester	-	23985-75-3	1066		no	no	0.05 mg/kg	Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).	Details
(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer	-	-	979	79987	yes	no		Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.	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
(methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer	-	-	1016		yes	no		Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA. The final material shall be used at room temperature or below.	Details
(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer	-	40471-03-2	867	40815	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.	Details
(butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate	-	-	866	40620	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.	Details
(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate	-	-	855	40560	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked	-	-	998		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene	-	-	859		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate	-	-	1043		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details

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