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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 101 - 200 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 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 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 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 2,6-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-(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-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-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 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-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 N-Heptylaminoundecanoic acid	-	-	731	18220	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 n-Octylphosphonic acid	-	-	483	68860	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 Styrenesuphonic acid	-	-	656	24760	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 Tricyclodecanedimethanol	-	-	655	25450	no	no	0.05 mg/kg		Details
Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (BTDA)	219-348-1	2421-28-5	1083		no	no	0.05 mg/kg	Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.	Details
bicyclo[2.2.1]hept-2-ene	207-866-0	498-66-8	341	22550 13180	no	no	0.05 mg/kg		Details
bis(2,6-diisopropylphenyl) carbodiimide	218-487-5	2162-74-5	438	13303	no	no	0.05 mg/kg	Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline	Details
bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH)	283-829-2	84731-70-4	1079		yes	no	0.05 mg/kg	Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.	Details
bis(4-aminocyclohexyl)methane	217-168-8	1761-71-3	429	13210	no	no	0.05 mg/kg		Details
cyclooctene	213-245-5	931-88-4	381	15030	no	no	0.05 mg/kg	Only to be used in polymers contacting foods for which simulant A is laid down.	Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
dioctadecyl disulphide	219-702-5	2500-88-1	449	49840	yes	yes	0.05 mg/kg		Details
diphenyl carbonate	203-005-8	102-09-0	201	16540	no	no	0.05 mg/kg		Details
formaldehyde-1-naphthol, copolymer	607-708-4	25359-91-5	640	54930	yes	no	0.05 mg/kg		Details
isobutyl vinyl ether	203-678-8	109-53-5	243	19060	no	no	0.05 mg/kg		Details
isophthalic acid, dimethyl ester	215-951-9	1459-93-4	420	19210	no	no	0.05 mg/kg		Details
methacrylic acid, allyl ester	202-473-0	96-05-9	175	20050	no	no	0.05 mg/kg		Details
methacrylic acid, cyclohexyl ester	202-943-5	101-43-9	197	20260	no	no	0.05 mg/kg		Details
methacrylic acid, diester with 1,4-butanediol	218-218-1	2082-81-7	434	20410	no	no	0.05 mg/kg		Details
methacrylic acid, diester with ethyleneglycol	202-617-2	97-90-5	185	20440	no	no	0.05 mg/kg		Details
methacrylic acid, sulphopropyl ester	-	54276-35-6	694	21400	no	no	0.05 mg/kg		Details
mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane	247-063-2	25513-64-8	641	22331	no	no	0.05 mg/kg		Details
montmorillonite clay modified by dimethyldialkyl (C16-C18)ammonium chloride	-	-	1030		yes	no	0.05 mg/kg	Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below. The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food. Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.	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'-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
N,N'-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide	-	132459-54-2	764	13317	no	no	0.05 mg/kg	Purity > 98,1 % (w/w). Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).	Details
N,N'-divinyl-2-imidazolidinone	237-457-2	13811-50-2	612	16694	no	no	0.05 mg/kg		Details
N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione	-	852282-89-4	809	49080	yes	yes	0.05 mg/kg	Only for use in PET.	Details
N-(2-aminoethyl)-β-alanine, sodium salt	282-811-1	84434-12-8	748	12765	no	no	0.05 mg/kg		Details
N-(2-aminoethyl)ethanolamine	203-867-5	111-41-1	262	35284	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
N-(4-hydroxyphenyl) acetamide	203-157-5	103-90-2	208	18898	no	no	0.05 mg/kg		Details
N-heptylaminoundecanoic acid	271-487-7	68564-88-5	731	18220	no	no	0.05 mg/kg		Details
N-methylolmethacrylamide	213-086-1	923-02-4	378	21970	no	no	0.05 mg/kg		Details
n-octylphosphonic acid	225-218-5	4724-48-5	483	68860	yes	no	0.05 mg/kg		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
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
perfluoromethyl perfluorovinyl ether	214-703-7	1187-93-5	391	22932	no	no	0.05 mg/kg	Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.	Details
perfluoropropylperfluorovinyl ether	216-600-2	1623-05-8	423	22937	no	no	0.05 mg/kg		Details
Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate	258-053-2	52628-03-2	1082		no	no	0.05 mg/kg	Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.	Details
phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters	-	-	68	73160	yes	yes	0.05 mg/kg		Details
Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly [oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters	843-672-8	1227937-46-3	1076		yes	no	0.05 mg/kg	Only to be used (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.	Details
polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate	-	-	76	77732	yes	no	0.05 mg/kg	Only for use in PET.	Details
polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate	-	-	77	77733	yes	no	0.05 mg/kg	Only for use in PET.	Details
pyromellitic anhydride	201-898-9	89-32-7	166	24057	no	no	0.05 mg/kg		Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
tetrafluoroethylene	204-126-9	116-14-3	281	25120	no	no	0.05 mg/kg		Details
trialkyl acetic acid (C7-C17), vinyl esters	-	-	6	25380	no	no	0.05 mg/kg		Details
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	no	0.05 mg/kg		Details
tricyclodecanedimethanol bis(hexahydrophthalate)	-	-	92	93970	yes	no	0.05 mg/kg		Details
trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids	-	-	924	94987	yes	no	0.05 mg/kg	Only for use in PET in contact with all types of foods other than fatty, high- alcoholic and dairy products.	Details
tungsten oxide	254-413-8	39318-18-8	1064		yes	no	0.05 mg/kg	Stoichiometry: WOn, n = 2,72-2,90.	Details
vinyltriethoxysilane	201-081-7	78-08-0	142	26305	no	no	0.05 mg/kg	Only to be used as a surface treatment agent.	Details
vinyltrimethoxysilane	220-449-8	2768-02-7	453	26320	no	no	0.05 mg/kg		Details
waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity	-	-	93	95858	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. Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).	Details
α-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl) propylsilyl polydimethylsiloxane	641-029-4	156065-00-8	874	16265	no	no	0.05 mg/kg	Only to be used as comonomer in siloxane modified polycarbonate. The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).	Details
α-methylstyrene	202-705-0	98-83-9	187	22210	no	no	0.05 mg/kg		Details
2-(4-dodecylphenyl)indole	257-624-3	52047-59-3	692	52320	yes	yes	0.06 mg/kg		Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no	0.12 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	685	85950	yes	no	0.15 mg/kg	SML expressed as fluoride. Only to be used in layers of multi-layer materials not coming into direct contact with food.	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
1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride	223-805-0	4080-31-3	474	43600	yes	no	0.3 mg/kg		Details
4,4'-thiobis(6-tert-butyl-3-methylphenol)	202-525-2	96-69-5	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 4,4'-Thiobis(6-tert-butyl-3-methylphenol)	-	-	178	92800	yes	yes	0.48 mg/kg		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
1,4-dihydroxybenzene	204-617-8	123-31-9	295	48620 15940 18867	yes	no	0.6 mg/kg		Details
2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene	230-426-4	7128-64-5	500	38560	yes	yes	0.6 mg/kg		Details
benzophenone	204-337-6	119-61-9	286	38240	yes	yes	0.6 mg/kg		Details
bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	247-952-5	26741-53-7	652	38820	yes	yes	0.6 mg/kg		Details
bis(polyethyleneglycol)hydroxymethylphosphonate	614-830-1	68951-50-8	735	40120	yes	no	0.6 mg/kg		Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no	0.6 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
sodium nitrite	231-555-9	7632-00-0	506	86920	yes	no	0.6 mg/kg		Details
tetrahydrofuran	203-726-8	109-99-9	246	25150	no	no	0.6 mg/kg		Details
chlorides of choline esters of coconut oil fatty acids	-	-	23	43515	yes	no	0.9 mg/kg		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
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
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	1 mg/kg	The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.	Details
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate	222-020-0	3319-31-1	1078		yes	no	1 mg/kg	Only to be used as plasticiser to manufacture soft poly(vinyl chloride). Not to be used in contact with foods intended for infants.	Details
2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole	274-570-6	70321-86-7	738	60320	yes	yes	1.5 mg/kg		Details
3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone	256-318-7	47465-97-4	691	13600	no	no	1.8 mg/kg		Details
bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride	228-253-4	6200-40-4	493	39200	yes	no	1.8 mg/kg		Details
polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols	-	-	799	77708	yes	no	1.8 mg/kg	In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.	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
sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts	-	-	814	91815	yes	no	2 mg/kg		Details
1,3-dihydroxybenzene	203-585-2	108-46-3	237	24072 15910	no	no	2.4 mg/kg		Details
hexamethylenediamine	204-679-6	124-09-4	305	18460 15274	no	no	2.4 mg/kg		Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer	-	61269-61-2	701	40160	yes	no	2.4 mg/kg		Details
phosphoric acid, diphenyl 2-ethylhexyl ester	214-987-2	1241-94-7	392	72800	yes	yes	2.4 mg/kg		Details
thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)	255-392-8	41484-35-9	690	92880	yes	yes	2.4 mg/kg		Details

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