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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 19 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)
4-hydroxybenzoic acid, isopropyl ester	224-069-3	4191-73-5	478	60180	yes	no			Details
4-hydroxybenzoic acid, methyl ester	202-785-7	99-76-3	189	60200	yes	no			Details
4-hydroxybenzoic acid, propyl ester	202-307-7	94-13-3	173	60240	yes	no			Details
4-methyl-1-pentene	211-720-1	691-37-2	366	22150	no	no	0.05 mg/kg		Details
4-tert-butylphenol	202-679-0	98-54-4	186	14020	no	no	0.05 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
5-ethylidenebicyclo[2,2,1]hept-2-ene	240-347-7	16219-75-3	621	17110	no	no	0.05 mg/kg		Details
5-sulphoisophthalic acid, monosodium salt, dimethyl ester	223-578-8	3965-55-7	471	24888	no	no	0.05 mg/kg		Details
5-sulphoisophthalic acid, salts	-	-	823	24889	no	no	5 mg/kg		Details
6-amino-1,3-dimethyluracil	229-662-0	6642-31-5	495	35160	yes	no	5 mg/kg		Details
6-hydroxy-2-naphthalenecarboxylic acid	240-759-7	16712-64-4	624	18897	no	no	0.05 mg/kg		Details
7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin	222-067-7	3333-62-8	465	68040	yes	no			Details
9,10-dihydroxy stearic acid	204-432-2	120-87-6	27	48960	yes	no	5 mg/kg		Details
9,10-dihydroxy stearic acid, oligomers	-	-	27	48960	yes	no	5 mg/kg		Details
9,9-bis(methoxymethyl)fluorene	682-678-3	182121-12-6	779	39815	yes	yes	0.05 mg/kg		Details
[3-(2,3-epoxypropoxy)propyl]trimethoxy silane	219-784-2	2530-83-8	1068		no	no		Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).	Details
[3-(methacryloxy)propyl]trimethoxysilane	219-785-8	2530-85-0	788	21498	no	no	0.05 mg/kg	Only to be used as a surface treatment agent of inorganic fillers.	Details
abietic acid	208-178-3	514-10-3	346	10030	no	no			Details
acetaldehyde	200-836-8	75-07-0	128	10060	no	no			Details
acetic acid	200-580-7	64-19-7	115	30000 10090	yes	no			Details
acetic acid, butyl ester	204-658-1	123-86-4	300	30045	yes	no			Details
acetic acid, ethyl ester	205-500-4	141-78-6	327	30140	yes	no			Details
acetic acid, vinyl ester	203-545-4	108-05-4	231	10120	no	no	12 mg/kg		Details
acetic anhydride	203-564-8	108-24-7	232	30280 10150	yes	no			Details
acetone	200-662-2	67-64-1	119	30295	yes	no			Details
acetylacetic acid, salts	-	-	7	30370	yes	no			Details
acetylated mono- and diglycerides of fatty acids	-	-	8	30401	yes	no			Details
acetylene	200-816-9	74-86-2	126	10210	no	no			Details
acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol	-	-	11	30960	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, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt	-	-	801	30607	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters	-	-	10	30612	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, 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), esters with pentaerythritol	-	-	880	31348	yes	no			Details
acids, fatty, from animal or vegetable food fats and oils	-	-	12	31328	yes	no			Details
acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled	500-231-1	68783-41-5	733	10599/93 10599/92A	no	no			Details
acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled	500-148-0	61788-89-4	705	10599/91 10599/90A	no	no			Details
acrylamide	201-173-7	79-06-1	145	10630	no	no	0.01 mg/kg		Details
acrylic acid	201-177-9	79-10-7	147	10690	no	no			Details
acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester SUMILIZER GS	413-850-6	123968-25-2	762	31530	yes	yes	5 mg/kg		Details
acrylic acid, 2-ethylhexyl ester	203-080-7	103-11-7	206	11500	no	no	0.05 mg/kg		Details
acrylic acid, 2-hydroxypropyl ester	213-663-8	999-61-1	385	11530	no	no	0.05 mg/kg	SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).	Details
acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester	262-634-6	61167-58-6	700	31520	yes	yes	6 mg/kg		Details
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no	0.05 mg/kg	SML expressed as acrylic acid, 2-ethylhexyl ester.	Details
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no			Details
acrylic acid, benzyl ester	219-673-9	2495-35-4	446	10750	no	no			Details
acrylic acid, dicyclopentenyl ester	235-697-2	12542-30-2	605	11005	no	no	0.05 mg/kg		Details
acrylic acid, dodecyl ester	218-463-4	2156-97-0	437	11245	no	no	0.05 mg/kg		Details
acrylic acid, ethyl ester	205-438-8	140-88-5	323	11470	no	no			Details
acrylic acid, isobutyl ester	203-417-8	106-63-8	218	11590	no	no			Details
acrylic acid, isopropyl ester	211-710-7	689-12-3	365	11680	no	no			Details
acrylic acid, methyl ester	202-500-6	96-33-3	176	11710	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
acrylic acid, monoester with ethyleneglycol	212-454-9	818-61-1	371	11830 11510	no	no			Details
acrylic acid, n-butyl ester	205-480-7	141-32-2	325	10780	no	no			Details
acrylic acid, n-octyl ester	219-696-4	2499-59-4	448	11890	no	no			Details
acrylic acid, propyl ester	213-120-5	925-60-0	380	11980	no	no			Details
acrylic acid, sec-butyl ester	221-072-1	2998-08-5	456	10810	no	no			Details
acrylic acid, tert-butyl ester	216-768-7	1663-39-4	425	10840	no	no			Details
acrylonitrile	203-466-5	107-13-1	225	12100	no	no	0.01 mg/kg		Details
adipic acid	204-673-3	124-04-9	303	31730 12130	yes	no			Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes			Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes	18 mg/kg		Details
adipic acid, divinyl ester	223-792-1	4074-90-2	473	12265	no	no	0.01 mg/kg	5 mg/kg in final product. Only to be used as co-monomer.	Details
adipic anhydride	218-001-1	2035-75-8	432	12280	no	no			Details
albumin	-	266309-43-7	1	12310	no	no			Details
albumin, coagulated by formaldehyde	-	-	2	12340	no	no			Details
alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)	-	-	3	12375	no	no			Details
alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)	-	-	13	33120	yes	no			Details
alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated	604-520-4	146340-15-0	802	33105	yes	no	5 mg/kg		Details
alginic acid	232-680-1	9005-32-7	566	33350	yes	no			Details
alkyl(C10-C21)sulphonic acid, esters with phenol	293-728-5	91082-17-6	884	34240	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
alkyl(C8-C22)sulphonic acids	-	-	16	34230	yes	no	6 mg/kg		Details
alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms	-	-	17	34281	yes	no			Details
alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines	-	-	15	34130	yes	yes	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 (1,3:2,4) diparamethyldibenylidene sorbitol	-	-	752	39890	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 1,2-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 1,3-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 1,4-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 1,4:3,6-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 1,6-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-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-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-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-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-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-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-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 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 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 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 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 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'-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 2,2,4,4-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-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 2,3,6-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 2,4-Bis(dodecylthiomethyl)-6-methylphenol	-	-	758	38940	yes	yes			Details

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