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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 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)
2,4,6-triamino-1,3,5-triazine	203-615-4	108-78-1	239	25420 19975 93720	yes	no	2.5 mg/kg		Details
1-hexene	209-753-1	592-41-6	356	18820	no	no	3 mg/kg		Details
2,6-di-tert-butyl-p-cresol	204-881-4	128-37-0	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-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 Phenol	-	-	241	22960	no	no	3 mg/kg		Details
diphenyl sulphone	204-853-1	127-63-9	313	51570 16650	yes	no	3 mg/kg		Details
N,N'-diphenylthiourea	203-004-2	102-08-9	200	51680	yes	yes	3 mg/kg		Details
phenol	203-632-7	108-95-2	241	22960	no	no	3 mg/kg		Details
poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]	615-678-9	71878-19-8	740	81200	yes	yes	3 mg/kg		Details
4-ethoxybenzoic acid, ethyl ester	245-818-0	23676-09-7	632	52880	yes	no	3.6 mg/kg		Details
2,6-di-tert-butyl-4-ethylphenol	223-945-2	4130-42-1	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 2,6-Di-tert-butyl-4-ethylphenol	-	-	477	46720	yes	yes	4.8 mg/kg		Details
1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane	217-420-7	1843-03-4	430	95600	yes	yes	5 mg/kg		Details
1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane	252-816-3	35958-30-6	679	39060	yes	yes	5 mg/kg		Details
1,2-bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine	500-311-6	136504-96-6	767	38510	yes	no	5 mg/kg		Details
1,3,5-tris (2,2-dimethylpropanamido)benzene	456-830-2	745070-61-5	784	95420	yes	no	5 mg/kg		Details
1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione	248-597-9	27676-62-6	661	95360	yes	yes	5 mg/kg		Details
1,3-dioxolane	211-463-5	646-06-0	363	16450	no	no	5 mg/kg		Details
1,4-cyclohexanedicarboxylic acid	214-068-6	1076-97-7	806	14876	no	no	5 mg/kg	Only to be used for manufacture of polyesters.	Details
1,4:3,6-dianhydrosorbitol	211-492-3	652-67-5	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
1,6-hexanediamine, N1,N6-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymer with 2,4-dichloro-6-(4-morpholinyl)-1,3,5-triazine	617-335-9	82451-48-7	790	80480	yes	no	5 mg/kg	Average molecular weight not less than 2400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.	Details
1-pentene	203-694-5	109-67-1	245	22900	no	no	5 mg/kg		Details
11-aminoundecanoic acid	219-417-6	2432-99-7	443	12788	no	no	5 mg/kg		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
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'-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate	617-688-9	85209-93-4	750	66350	yes	no	5 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
2,2,4,4-tetramethylcyclobutane-1,3-diol	221-140-0	3010-96-6	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
2,2,4-trimethyl-1,3-pentanediol diisobutyrate	229-934-9	6846-50-0	497	95020	yes	no	5 mg/kg	Only to be used in single-use gloves.	Details
2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl-(''SPG'')	604-479-2	1455-42-1	1052		no	no	5 mg/kg	Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).	Details
2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine	412-440-4	2725-22-6	452	38885	yes	no	5 mg/kg		Details
2,4-diamino-6-hydroxypyrimidine	200-254-4	56-06-4	864	46330	yes	no	5 mg/kg	Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.	Details
2,4-diamino-6-phenyl-1,3,5-triazine	202-095-6	91-76-9	168	13075 15310	no	no	5 mg/kg		Details
2,6-naphthalenedicarboxylic acid	214-527-0	1141-38-4	389	22360	no	no	5 mg/kg		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
4,4'-diaminodiphenyl sulphone	201-248-4	80-08-0	153	15267	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
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
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
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
alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated	604-520-4	146340-15-0	802	33105	yes	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 1,4-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 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 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 2,6-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 Bis(4-propylbenzylidene)propylsorbitol	-	-	808	38550	yes	no	5 mg/kg	SML including the sum of its hydrolysis products.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Furan-2,5-dicarboxylic acid	-	-	1031		no	no	5 mg/kg	Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).	Details
aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate]	430-650-4	151841-65-5	771	34650	yes	no	5 mg/kg		Details
bis(2,4-dicumylphenyl)pentaerythritol-diphosphite	421-920-2	154862-43-8	773	38840	yes	yes	5 mg/kg	SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol).	Details
bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite ADK STAB PEP-36	410-290-4	80693-00-1	746	38810	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	Details
bis(4-propylbenzylidene)propylsorbitol	618-128-6	882073-43-0	808	38550	yes	no	5 mg/kg	SML including the sum of its hydrolysis products.	Details
cis-1,2-cyclohexanedicarboxylic acid, salts	-	-	816	45704	yes	no	5 mg/kg		Details
cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts	-	-	817	38507	yes	no	5 mg/kg	Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %.	Details
diethylenetriamine	203-865-4	111-40-0	261	15790	no	no	5 mg/kg		Details
furan-2,5-dicarboxylic acid	221-800-8	3238-40-2	1031		no	no	5 mg/kg	Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).	Details
laurolactam	213-424-8	947-04-6	382	19490	no	no	5 mg/kg		Details
methallylsulphonic acid, salts	-	-	818	21530	no	no	5 mg/kg		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
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'-dicyclohexyl-2,6-naphthalene dicarboxamide	-	153250-52-3	772	47500	yes	no	5 mg/kg		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
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
octadecylerucamide	233-226-5	10094-45-8	587	68400	yes	yes	5 mg/kg		Details
oleylpalmitamide	240-367-6	16260-09-6	622	69840	yes	yes	5 mg/kg		Details
p-cresol-dicyclopentadiene-isobutylene, copolymer	271-867-2	68610-51-5	732	45450	yes	yes	5 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
poly(12-hydroxystearic acid) stearate	500-140-7	58128-22-6	875	80345	yes	yes	5 mg/kg		Details
poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] hexa-methylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]	-	90751-07-8	790	80480	yes	no	5 mg/kg	Average molecular weight not less than 2400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.	Details
poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-α-[N,N,N',N'-tetrabutyl-N''-(2,2,6,6-tetramethyl-4-piperidinyl)-N''-[6-(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-triamine]-ω-N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine]	606-265-4	192268-64-7	780	81220	yes	no	5 mg/kg		Details
polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, salts	-	-	78	77897	yes	no	5 mg/kg		Details
polyethyleneglycol tridecyl ether phosphate	618-558-4	9046-01-9	578	79600	yes	no	5 mg/kg	For materials and articles intended for contact with aqueous foods only. Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.	Details
sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts	-	-	813	91530	yes	no	5 mg/kg		Details
triisopropanolamine	204-528-4	122-20-3	292	94560	yes	no	5 mg/kg		Details
trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid	-	-	815	94985	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
trioxane	203-812-5	110-88-3	255	25900	no	no	5 mg/kg		Details
vinylidene fluoride	200-867-7	75-38-7	132	26140	no	no	5 mg/kg		Details
1,1,1-trimethylolpropane	201-074-9	77-99-6	141	94960 25600 13380	yes	no	6 mg/kg		Details
1,2-dihydroxybenzene	204-427-5	120-80-9	289	24051 15880	no	no	6 mg/kg		Details
1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione	254-996-9	40601-76-1	689	95280	yes	yes	6 mg/kg		Details
1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)	252-346-9	35074-77-2	678	59200	yes	yes	6 mg/kg		Details
1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane	220-666-8	2855-13-2	454	12670	no	no	6 mg/kg		Details
2,2'-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite	403-020-1	118337-09-0	759	54300	yes	yes	6 mg/kg		Details
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt	265-512-0	65140-91-2	715	46880	yes	no	6 mg/kg		Details
4,4'-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)	235-841-4	13003-12-8	608	40800	yes	yes	6 mg/kg		Details
4,4'-dihydroxybiphenyl	202-200-5	92-88-6	170	16000	no	no	6 mg/kg		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
alkyl(C8-C22)sulphonic acids	-	-	16	34230	yes	no	6 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 Oxalic acid	-	-	333	22775 69920	yes	no	6 mg/kg		Details
chlorodifluoromethane	200-871-9	75-45-6	134	43680	yes	no	6 mg/kg	Content of chlorofluoromethane less than 1 mg/kg of the substance.	Details
ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]	251-073-2	32509-66-3	673	53670	yes	yes	6 mg/kg		Details
hexadecyltrimethylammonium bromide	200-311-3	57-09-0	104	58960	yes	no	6 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
oxalic acid	205-634-3	144-62-7	333	22775 69920	yes	no	6 mg/kg		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
polydimethylsiloxane, γ-hydroxypropylated	-	-	71	76730	yes	no	6 mg/kg		Details
thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate) SYNESAL M	404-440-8	120218-34-0	761	92930	yes	no	6 mg/kg		Details

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