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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 951 - 1,000 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
2,2'-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite	403-020-1	118337-09-0	759	54300	yes	yes	6 mg/kg		Details
2,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite	423-560-1	161717-32-4	774	95270	yes	yes	2 mg/kg	SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP.	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-bis(dodecylthiomethyl)-6-methylphenol	438-600-3	110675-26-8	758	38940	yes	yes			Details
2,4-bis(octylthiomethyl)-6-methylphenol CG 25-1320; IRGANOX 1520; TK 12229/1	402-860-6	110553-27-0	756	40020	yes	yes			Details
2,4-dimethyl-6-(1-methylpentadecyl)phenol CG 27-145	411-220-5	134701-20-5	765	49485	yes	yes	1 mg/kg		Details
2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol CG 30-1577	411-380-6	147315-50-2	770	51700	yes	no	0.05 mg/kg		Details
2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine	455-890-7	6607-41-6	872		no	no	0.05 mg/kg	To be used only as a co-monomer in polycarbonate copolymers.	Details
3,3-bis(methoxymethyl)-2,5-dimethylhexane	430-800-9	129228-21-3	763	39925	yes	yes	0.05 mg/kg		Details
3,4-diacetoxy-1-butene 3,4-DIACETOXY-1-BUTENE	421-720-5	18085-02-4	862	15180	no	no	0.05 mg/kg	SML including the hydrolysis product 3,4- dihydroxy-1-butene. Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.	Details
3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5] undecane ADK STAB AO 80; SUMILIZER GA-80	410-730-5	90498-90-1	858	38565	yes	yes	0.05 mg/kg	SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer.	Details
3-(3,5-di-tert-butyl-4-hydroxyphenyl) propanoic acid, esters with C13-C15 branched and linear alcohols ANOX 1315; ANOX BF; DURAD AX 38	413-750-2	171090-93-0	895	47060	yes	no	0.05 mg/kg	Only to be used in polyolefins in contact with foods other than fatty/ high-alcoholic and dairy products.	Details
4,4'-methylenebis(3-chloro-2,6-diethylaniline)	402-130-7	106246-33-7	755	21765	no	no	0.05 mg/kg		Details
4,4'-oxybis(benzenesulphonyl azide)	431-850-4	7456-68-0	502	22778	no	no	0.05 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
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
amines, bis(hydrogenated tallow alkyl) oxidised	418-370-0	143925-92-2	768	34850	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.	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(3,4-dimethylbenzylidene)sorbitol	413-110-2	135861-56-2	766	38879	yes	no			Details
bis(4-ethylbenzylidene)sorbitol NC-4	406-176-9	79072-96-1	743	38950	yes	no			Details
bis(methylbenzylidene)sorbitol CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005	402-950-5	87826-41-3	752	39890	yes	no			Details
ethylene-vinyl acetate copolymer wax	429-840-1	24937-78-8	969		yes	no		Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.	Details
glycerides, castor-oil mono-, hydrogenated, acetates	451-530-8	736150-63-3	783	55910	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
pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)	429-160-3	178671-58-4	778	71670	yes	yes	0.05 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
reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous trichloride and biphenyl	432-130-2	119345-01-6	760	83595	yes	no	18 mg/kg	Composition: 4,4'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w ()),4,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w ()),3,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w ()),4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w ()),tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w ()),4,4'-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w ())(*)Quantity of substance used/quantity of formulationOther specifications: Phosphor content of min. 5,4 % to max. 5,9 %,Acid value of max. 10 mg KOH per gram,Melt range of 85- 110 °C.	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
vermiculite, reaction product with citric acid, lithium salt MICROLITE (R) POWDER; MICROLITE (R) VERMICULITE DISPERSIONS; MICROLITE POWDER; MICROLITE SPECIALITY VERMICULITE; MICROLITE VERMICULITE DISPERSIONS; MICROLITE-VERMICULITDISPERSIONEN	406-060-8	110638-71-6	757	95725	yes	no			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
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
poly(12-hydroxystearic acid) stearate	500-140-7	58128-22-6	875	80345	yes	yes	5 mg/kg		Details
polyethyleneglycol 1 - 4.5 moles ethoxylated	500-038-2	25322-68-3	638	23590 76960	yes	no			Details
polyethyleneglycol ester of castor oil 1 - 6.5 moles ethoxylated	500-151-7	61791-12-6	708	77520	yes	no	42 mg/kg		Details
polyethyleneglycol ester of hydrogenated castor oil 1 - 6.5 moles ethoxylated	500-147-5	61788-85-0	704	77600	yes	no			Details
polyethyleneglycol sorbitan monolaurate 1 - 6.5 moles ethoxylated	500-018-3	9005-64-5	568	79040	yes	no			Details
polyethyleneglycol sorbitan monooleate 1 - 6.5 moles ethoxylated	500-019-9	9005-65-6	569	79120	yes	no			Details
polyethyleneglycol sorbitan monostearate 1 - 6.5 moles ethoxylated	500-020-4	9005-67-8	571	79280	yes	no			Details
polypropyleneglycol 1 - 4.5 moles propoxylated	500-039-8	25322-69-4	639	23651 80800	yes	no			Details
(1,3:2,4) diparamethyldibenylidene sorbitol	617-241-8	81541-12-0	752	39890	yes	no			Details
(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer	607-698-1	25322-99-0	865	40619	yes	no		Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.	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
(ethyl acrylate, methyl methacrylate) copolymer	618-459-6	9010-88-2	868	53245	yes	no		Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.	Details
1,2-propyleneglycol alginate	618-414-0	9005-37-2	567	82080	yes	no			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

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