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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 1,001 - 1,050 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 α-Tocopherol	-	-	110	93520	yes	no			Details
alpha-tocopherol	200-412-2	59-02-9	110	93520	yes	no			Details
DL-alpha-tocopherol	233-466-0	10191-41-0	110	93520	yes	no			Details
tragacanth gum	232-552-5	9000-65-1	545	93680	yes	no			Details
tri-n-butyl acetyl citrate	201-067-0	77-90-7	138	93760	yes	no			Details
tricyclodecanedimethanol bis(hexahydrophthalate)	-	-	92	93970	yes	no	0.05 mg/kg		Details
triethanolamine	203-049-8	102-71-6	793	94000	yes	no			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
triethyl phosphonoacetate	212-757-6	867-13-0	800	94425	yes	no		Only for use in PET.	Details
triisopropanolamine	204-528-4	122-20-3	292	94560	yes	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
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, 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 trimethacrylate-methyl methacrylate copolymer	927-697-2	28931-67-1	664	95000	yes	no			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
1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene	216-971-0	1709-70-2	428	95200	yes	no			Details
1,3,5-tris(4-benzoylphenyl) benzene	-	227099-60-7	781	95265	yes	no	0.05 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
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
1,3,5-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
1,3,5-tris (2,2-dimethylpropanamido)benzene	456-830-2	745070-61-5	784	95420	yes	no	5 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
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
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
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
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
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
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
wollastonite	237-772-5	13983-17-0	613	95905	yes	no			Details
xanthan gum	234-394-2	11138-66-2	596	95935	yes	no			Details
zinc hydroxide	243-814-3	20427-58-1	628	96190	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 sulphide	215-251-3	1314-98-3	403	96320	yes	no			Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate	-	-	1043		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene	-	-	859		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked	-	-	998		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer	-	-	1016		yes	no		Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA. The final material shall be used at room temperature or below.	Details
(triethanolamine-perchlorate, sodium salt) dimer	480-340-8	156157-97-0	1080		yes	no		Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.	Details
(triethanolamine-perchlorate, sodium salt) dimer	480-340-8	156157-97-0	1080		yes	no		Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.	Details
1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester	-	23985-75-3	1066		no	no	0.05 mg/kg	Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).	Details
1,2-benziso-thiazol-3(2H)-one 1,1-dioxide, sodium salt	204-886-1	128-44-9	902		yes	no		The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (OJ L 83, 22.3.2012, p. 1).	Details
1,3-bis(isocyanatomethyl)benzene	222-852-4	3634-83-1	988		no	no		SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine. To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.	Details
1,7-octadiene	223-054-9	3710-30-3	1034		no	no	0.05 mg/kg	Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.	Details
2,3,3,4,4,5,5-heptafluoro-1-pentene	-	1547-26-8	1063		no	no		Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.	Details
2,4,4'-trifluorobenzophenone	813-638-7	80512-44-3	1061		no	no		Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.	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-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
2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]	-	37486-69-4	903		yes	no		Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.	Details
[3-(2,3-epoxypropoxy)propyl]trimethoxy silane	219-784-2	2530-83-8	1068		no	no		Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).	Details

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