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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 24 April 2024. Database contains 1080 unique substances/entries.

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Showing 1 - 100 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
β-pinene	204-872-5	127-91-3	314	23500	no	no			Details
β-dextrin	231-493-2	7585-39-9	503	46080	yes	no			Details
α-pinene	201-291-9	80-56-8	155	23470	no	no			Details
α-methylstyrene	202-705-0	98-83-9	187	22210	no	no	0.05 mg/kg		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-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		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-dextrin	233-007-4	10016-20-3	580	46070	yes	no			Details
α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine	604-838-3	152261-33-1	803	33535	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Not to be used in contact with alcoholic foods.	Details
zinc sulphide	215-251-3	1314-98-3	403	96320	yes	no			Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	402	96240	yes	no			Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	1050		yes	no		Only to be used in unplasticised polymers.	Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	1046		yes	no		Only to be used in unplasticised polymers. The restrictions and specifications specified for FCM substance No 788 shall be respected.	Details
zinc hydroxide	243-814-3	20427-58-1	628	96190	yes	no			Details
xanthan gum	234-394-2	11138-66-2	596	95935	yes	no			Details
wollastonite	237-772-5	13983-17-0	613	95905	yes	no			Details
white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks	-	-	95	95883	yes	no		Average molecular weight not less than 480 Da. Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)	Details
waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity	-	-	94	95859	yes	no		Average molecular weight not less than 500 Da. Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)	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
water	231-791-2	7732-18-5	515	95855 26360	yes	no		In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].	Details
vinyltrimethoxysilane	220-449-8	2768-02-7	453	26320	no	no	0.05 mg/kg		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
vinylidene fluoride	200-867-7	75-38-7	132	26140	no	no	5 mg/kg		Details
vinylidene chloride	200-864-0	75-35-4	130	26110	no	no	0.01 mg/kg		Details
vinyl chloride	200-831-0	75-01-4	127	26050	no	no	0.01 mg/kg	1 mg/kg in final product.	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
urea	200-315-5	57-13-6	107	25960	no	no			Details
tungsten oxide	254-413-8	39318-18-8	1064		yes	no	0.05 mg/kg	Stoichiometry: WOn, n = 2,72-2,90.	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
tripropyleneglycol	246-466-0	24800-44-0	634	25910	no	no			Details
trioxane	203-812-5	110-88-3	255	25900	no	no	5 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
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
trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid	-	-	815	94985	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
trimethylolpropane trimethacrylate-methyl methacrylate copolymer	927-697-2	28931-67-1	664	95000	yes	no			Details
trimethyl trimellitate	219-547-3	2459-10-1	971	25885	no	no		Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.	Details
trimellitic anhydride	209-008-0	552-30-7	349	25550	no	no			Details
trimellitic acid	208-432-3	528-44-9	347	25540 13050	no	no			Details
triisopropanolamine	204-528-4	122-20-3	292	94560	yes	no	5 mg/kg		Details
triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]	253-039-2	36443-68-2	680	94400	yes	no	9 mg/kg		Details
triethyleneglycol	203-953-2	112-27-6	266	25510 94320	yes	no			Details
triethyl phosphonoacetate	212-757-6	867-13-0	800	94425	yes	no		Only for use in PET.	Details
triethanolamine	203-049-8	102-71-6	793	94000	yes	no			Details
tricyclodecanedimethanol bis(hexahydrophthalate)	-	-	92	93970	yes	no	0.05 mg/kg		Details
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	no	0.05 mg/kg		Details
triallylamine	203-048-2	102-70-5	205	25385	no	no		40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. Only to be used in hydrogels intended for non-direct food contact use.	Details
trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester	-	-	5	25360	no	no	0.01 mg/kg	1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	Details
trialkyl acetic acid (C7-C17), vinyl esters	-	-	6	25380	no	no	0.05 mg/kg		Details
tri-n-butyl acetyl citrate	201-067-0	77-90-7	138	93760	yes	no			Details
tragacanth gum	232-552-5	9000-65-1	545	93680	yes	no			Details
tocopherol acetate	231-710-0	7695-91-2	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
titanium nitride	247-117-5	25583-20-4	807	93485	yes	no		No migration of titanium nitride nanoparticles. Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg. In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.	Details
titanium nitride	234-354-4	11116-16-8	807	93485	yes	no		No migration of titanium nitride nanoparticles. Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg. In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.	Details
titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt]	-	-	805	93450	yes	no		The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w.	Details
Titanium dioxide surface-treated with fluoride-modified alumina	-	-	1077		yes	no		Only to be used at up to 25.0 % w/w, including in the nanoform.	Details
titanium dioxide reacted with octyltriethoxysilane	-	-	873	93460	yes	no		Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.	Details
titanium dioxide	236-675-5	13463-67-7	610	93440	yes	no			Details
thiodipropionic acid, ditetradecyl ester	240-613-2	16545-54-3	894	93360	yes	no			Details
thiodipropionic acid, dioctadecyl ester	211-750-5	693-36-7	368	93280	yes	yes			Details
thiodipropionic acid, didodecyl ester	204-614-1	123-28-4	294	93120	yes	yes			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
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
tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-biphenylylene diphosphonite	254-037-4	38613-77-3	688	92560	yes	yes	18 mg/kg		Details
tetrahydrofuran	203-726-8	109-99-9	246	25150	no	no	0.6 mg/kg		Details
tetrafluoroethylene	204-126-9	116-14-3	281	25120	no	no	0.05 mg/kg		Details
tetraethyleneglycol	203-989-9	112-60-7	269	92350 25090	yes	no			Details
tetradecyl-polyethyleneglycol(EO = 3-8) ether of glycolic acid	-	-	91	92320	yes	yes	15 mg/kg		Details
tert-butyl-4-hydroxyanisole	246-563-8	25013-16-5	635	40720	yes	no	30 mg/kg		Details
terephthalic acid, dimethyl ester	204-411-8	120-61-6	288	24970	no	no			Details
terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)	260-815-4	57569-40-1	696	92205	yes	no			Details
terephthalic acid, bis(2-ethylhexyl)ester	229-176-9	6422-86-2	798	92200	yes	no	60 mg/kg		Details
terephthalic acid, bis(2-ethylhexyl)ester	229-176-9	6422-86-2	798	92200	yes	no			Details
terephthalic acid dichloride	202-829-5	100-20-9	191	24940	no	no			Details
terephthalic acid	202-830-0	100-21-0	785	24910	no	no			Details
taurine, salts	-	-	90	92195	yes	no			Details
tannic acids Gallic acid derivatives found in nutgalls, bark and other plant parts, especially oak bark.	215-753-2	1401-55-4	419	92150	yes	no		According to the JECFA specifications.	Details
talc	238-877-9	14807-96-6	615	92080	yes	no			Details
syrups, hydrolysed starch, hydrogenated	270-337-8	68425-17-2	724	24903	no	no		In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].	Details
sulphuric acid	231-639-5	7664-93-9	511	91920	yes	no			Details
sulphur	231-722-6	7704-34-9	514	91840	yes	no			Details
sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts	-	-	814	91815	yes	no	2 mg/kg		Details
sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts	-	-	813	91530	yes	no	5 mg/kg		Details
sucrose octaacetate	204-772-1	126-14-7	309	91360	yes	no			Details
sucrose acetate isobutyrate	204-771-6	126-13-6	308	91200	yes	no			Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
succinic anhydride	203-570-0	108-30-5	233	24850	no	no			Details
succinic acid	203-740-4	110-15-6	247	90960 24820	yes	no			Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
STYRENE, POLYMER WITH 1,3-BUTADIENE, BUTYL ACRYLATE AND METHYL METHACRYLATE	843-371-1	25101-28-4	856	40563	yes	no		Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.	Details
styrene	202-851-5	100-42-5	193	24610	no	no			Details
stearoylbenzoylmethane	261-257-4	58446-52-9	699	90720	yes	no			Details
stearoyl-2-lactylic acid, salts	-	-	821	90810	yes	no			Details
stearic acid, esters with ethyleneglycol	-	-	89	89440	yes	no			Details
stearic acid, butyl ester	204-666-5	123-95-5	301	89120	yes	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	yes	no			Details
stearamide	204-693-2	124-26-5	306	88960	yes	no			Details
starch, hydrolysed	686-629-7	68412-29-3	723	88880	yes	no			Details
starch, edible High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.	232-679-6	9005-25-8	564	24540 88800	yes	no			Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	60 mg/kg		Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no			Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	30 mg/kg	In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.	Details

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