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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 901 - 950 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
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
diethyl[[3,5-bis (1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate	213-551-9	976-56-7	1007		no	no		Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)	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
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
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
(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
(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
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
3H-perfluoro-3-[(3-methoxy-propoxy) propanoic acid], ammonium salt	-	958445-44-8	896	71958	yes	no		Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.	Details
perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt	700-323-3	908020-52-0	926	71955	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.	Details
perfluoro[2-(poly(n-propoxy))propanoic acid]	680-272-0	51798-33-5	860	71980	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.	Details
perfluoro[2-(n-propoxy)propanoic acid]	236-236-8	13252-13-6	861	71990	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Perfluoro[2-(n-propoxy)propanoic acid]	-	-	861	71990	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.	Details
mixture of methylbranched and linear C14-C18 alkanamides, derived from fatty acids	288-287-0	85711-28-0	1065		yes	no	5 mg/kg	Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.	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
2,4-diamino-6-hydroxypyrimidine	200-254-4	56-06-4	864	46330	yes	no	5 mg/kg	Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.	Details
(butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate	-	-	866	40620	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.	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
(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer	-	40471-03-2	867	40815	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.	Details
(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer	-	37953-21-2	857	66765	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.	Details
(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate	-	-	855	40560	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % 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
perfluorooctanoic acid, ammonium salt	223-320-4	3825-26-1	468	71960	yes	no		Only to be used in repeated use articles, sintered at high temperatures.	Details
3-methyl-1-butene	209-249-1	563-45-1	351	21730	no	no	0.01 mg/kg	Only to be used in polypropylene.	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
dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene	-	287916-86-3	871		yes	no		Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.	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
(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer	-	-	979	79987	yes	no		Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,1,1-Tris(4-hydroxyphenol)ethane	-	-	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
1,1,1-tris(4-hydroxyphenol)ethane THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE	405-800-7	27955-94-8	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
3,3'-dimethyl-4,4'-diaminodicyclohexylmethane	229-962-1	6864-37-5	498	16210	no	no	0.05 mg/kg	Only to be used in polyamides.	Details
cyclic oligomers of (butylene terephthalate)	-	263244-54-8	885	45676	yes	no		Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.	Details
poly(12-hydroxystearic acid)-polyethyleneimine copolymer	630-556-5	124578-12-7	812	80350	yes	no		Only to be used in plastics up to 0,1 % w/w. Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.	Details
3-methyl-1,5-pentanediol	224-709-1	4457-71-0	883	22074	no	no	0.05 mg/kg	Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg.	Details
perfluoro acetic acid, α-substituted with the copolymer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groups	682-234-9	329238-24-6	854	71943	yes	no		Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles.	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
iron phosphide	235-798-1	12751-22-3	607	62245	yes	no		Only to be used in PET polymers and copolymers	Details
mixture composed of 97 % tetraethyl orthosilicate (TEOS) with CAS No 78-10-4 and 3 % hexamethyldisilazane (HMDS) with CAS No 999-97-3	-	-	1062		no	no		Only to be used for the production of recycled PET and at up to 0,12 % (w/w).	Details
glycolic acid	201-180-5	79-14-1	794	18117	no	no		Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Glycolic acid	-	-	794	18117	no	no		Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,4-Cyclohexanedicarboxylic acid	-	-	806	14876	no	no	5 mg/kg	Only to be used for manufacture of polyesters.	Details
1,4-cyclohexanedicarboxylic acid	214-068-6	1076-97-7	806	14876	no	no	5 mg/kg	Only to be used for manufacture of polyesters.	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
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
N,N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids	-	-	1081		yes	no		Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III.	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
ground sunflower seed hulls	-	-	1060		yes	no		Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E. The seed hulls shall be obtained from sunflower seeds that are fit for human consumption. The processing temperature of the plastic containing the additive shall not exceed 240 °C.	Details
phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 show/hide Di-''isononyl'' phthalate EC / List no: 249-079-5 \| CAS no: 28553-12-0 Di-''isodecyl'' phthalate EC / List no: 247-977-1 \| CAS no: 26761-40-0 6-methylheptyl 8-methylnonyl phthalate EC / List no: 204-293-8 \| CAS no: 119-05-1 Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 \| CAS no: 85391-49-7 2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 \| CAS no: 85851-77-0 Bis(1-methylheptyl) phthalate EC / List no: 205-014-2 \| CAS no: 131-15-7 2-ethylhexyl octyl phthalate EC / List no: 701-508-1 \| CAS no: 3461-26-5 4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 \| CAS no: 85851-78-1 1,2-Benzenedicarboxylic acid, bis(2,5-dimethylhexyl) ester EC / List no: - \| CAS no: 104719-70-2 3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 \| CAS no: 85851-80-5 Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 \| CAS no: 85851-81-6 2-ethylhexyl isononyl phthalate EC / List no: 288-652-4 \| CAS no: 85851-92-9 Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 \| CAS no: 89-16-7 Bis(2-ethylhexyl) phthalate EC / List no: 204-211-0 \| CAS no: 117-81-7 Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 \| CAS no: 70152-36-2 Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 \| CAS no: 14103-61-8 3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 \| CAS no: 85851-79-2 1,2-Benzenedicarboxylic acid, bis-(1-ethylhexyl) ester EC / List no: - \| CAS no: 15495-94-0 2-ethylhexyl 8-methylnonyl phthalate EC / List no: 201-883-7 \| CAS no: 89-13-4 Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 \| CAS no: 70857-56-6 3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 \| CAS no: 97692-55-2 Isononyl isooctyl phthalate EC / List no: 306-190-4 \| CAS no: 96532-79-5 2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 \| CAS no: 85851-76-9 Diisooctyl phthalate EC / List no: 248-523-5 \| CAS no: 27554-26-3 1,2-Benzenedicarboxylic acid, bis(2-propylpentyl) ester EC / List no: - \| CAS no: 70910-37-1 Isodecyl isononyl phthalate EC / List no: 285-916-0 \| CAS no: 85168-75-8 Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 \| CAS no: 85391-48-6 2-ethylhexyl nonyl phthalate EC / List no: 288-646-1 \| CAS no: 85851-86-1 Isodecyl isooctyl phthalate EC / List no: 255-760-8 \| CAS no: 42343-35-1 Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 \| CAS no: 85391-50-0 Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 \| CAS no: 85851-84-9 Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 \| CAS no: 53306-54-0 Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 \| CAS no: 85391-51-1 2-ethylhexyl isodecyl phthalate EC / List no: 258-455-8 \| CAS no: 53272-22-3	-	-	728	75100	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085.	Details

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