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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 1 - 50 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-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	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 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 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
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
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
tripropyleneglycol	246-466-0	24800-44-0	634	25910	no	no			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
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
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
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
tetraethyleneglycol	203-989-9	112-60-7	269	92350 25090	yes	no			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			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

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