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

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Showing 401 - 500 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
1,1,1-trimethylolpropane trimethacrylate	221-950-4	3290-92-4	463	25840	no	no	0.05 mg/kg		Details
N,N'-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide	251-156-3	32687-78-8	675	38800	yes	yes	15 mg/kg		Details
dibenzylidene sorbitol	251-136-4	32647-67-9	674	46480	yes	no			Details
ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]	251-073-2	32509-66-3	673	53670	yes	yes	6 mg/kg		Details
furan-2,5-dicarboxylic acid	221-800-8	3238-40-2	1031		no	no	5 mg/kg	Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).	Details
mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate	915-277-1	32052-51-0	4	22332	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
N-vinyl-N-methylacetamide	221-698-5	3195-78-6	462	26170	no	no	0.02 mg/kg		Details
polyester of 1,4-butanediol with caprolactone	608-670-1	31831-53-5	672	76845	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).	Details
polyester of 1,4-butanediol with caprolactone	608-670-1	31831-53-5	672	76845	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).	Details
1,5-naphthalene diisocyanate	221-641-4	3173-72-6	461	22420	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
cyclohexyl isocyanate	221-639-3	3173-53-3	460	14950	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
phosphorous acid, tris(2,4-di-tert-butylphenyl)ester	250-709-6	31570-04-4	671	74240	yes	no			Details
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester	221-532-1	3135-18-0	459	46870	yes	no			Details
glycerol monolaurate diacetate	250-379-3	30899-62-8	670	56800	yes	no			Details
glass microballs	919-828-7	308066-94-6	39	55600	yes	no			Details
behenamide	221-304-1	3061-75-4	458	36960	yes	no			Details
glycerol monobehenate	250-097-0	30233-64-8	669	56610	yes	no			Details
2,2,4,4-tetramethylcyclobutane-1,3-diol	221-140-0	3010-96-6	881	25187	no	no	5 mg/kg	Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.	Details
oleamide	206-103-9	301-02-0	335	68960	yes	no			Details
methacrylic acid, sec-butyl ester	221-073-7	2998-18-7	457	20140	no	no			Details
acrylic acid, sec-butyl ester	221-072-1	2998-08-5	456	10810	no	no			Details
polyglycerol ricinoleate	608-428-5	29894-35-7	668	80240	yes	no			Details
gadoleic acid	-	29204-02-2	667	55190	yes	no			Details
sorbitan dioleate	249-448-0	29116-98-1	666	87280	yes	no			Details
1,2-propyleneglycol monopalmitate	249-369-1	29013-28-3	665	83120	yes	no			Details
trimethylolpropane trimethacrylate-methyl methacrylate copolymer	927-697-2	28931-67-1	664	95000	yes	no			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
methacrylic acid, 2-(dimethylamino)-ethyl ester	220-688-8	2867-47-2	455	20530	no	no	0.01 mg/kg		Details
diisononyl phthalate	249-079-5	28553-12-0	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
diisononyl phthalate	249-079-5	28553-12-0	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
1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane	220-666-8	2855-13-2	454	12670	no	no	6 mg/kg		Details
linolenic acid	217-792-0	28290-79-1	663	64150	yes	no			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
vinyltrimethoxysilane	220-449-8	2768-02-7	453	26320	no	no	0.05 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
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine	412-440-4	2725-22-6	452	38885	yes	no	5 mg/kg		Details
1,2-propyleneglycol monolaurate	248-315-4	27194-74-7	659	82800	yes	no			Details
dodecylbenzenesulphonic acid	248-289-4	27176-87-0	658	52000	yes	no	30 mg/kg		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
mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)	248-227-6	27107-89-7	657	67680	yes	no			Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	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
sorbitol monostearate	248-027-9	26836-47-5	654	88600	yes	no			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
diisodecyl phthalate	247-977-1	26761-40-0	729	75105	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 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;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
diisodecyl phthalate	247-977-1	26761-40-0	729	75105	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 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;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
2,4-toluene diisocyanate dimer	247-953-0	26747-90-0	653	25270	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	247-952-5	26741-53-7	652	38820	yes	yes	0.6 mg/kg		Details
sorbitan tristearate	247-891-4	26658-19-5	651	88240	yes	no			Details
dimethyltin bis(isooctyl mercaptoacetate)	247-862-6	26636-01-1	650	49600	yes	no			Details
albumin	-	266309-43-7	1	12310	no	no			Details
dibutylthiostannoic acid polymer	-	26427-07-6	649	47210	yes	no		Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).	Details
glycerol monooctanoate	247-668-1	26402-26-6	648	56880	yes	no			Details
glycerol monohexanoate	-	26402-23-3	647	56720	yes	no			Details
di-n-octyltin bis(isooctyl mercaptoacetate)	247-666-0	26401-97-8	646	50480	yes	no			Details
mono-n-octyltin tris(isooctyl mercaptoacetate)	247-665-5	26401-86-5	645	67760	yes	no			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
sorbitan trioleate	247-569-3	26266-58-0	644	88080	yes	no			Details
sorbitan monopalmitate	247-568-8	26266-57-9	643	87760	yes	no			Details
maleic anhydride-styrene, copolymer, sodium salt	607-789-6	25736-61-2	642	64990	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 0,05 % (w/w).	Details
polyglycerol	607-759-2	25618-55-7	1017		yes	no		To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.	Details
sebacic anhydride	219-882-5	2561-88-8	450	24430	no	no			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
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
formaldehyde-1-naphthol, copolymer	607-708-4	25359-91-5	640	54930	yes	no	0.05 mg/kg		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
polypropyleneglycol 1 - 4.5 moles propoxylated	500-039-8	25322-69-4	639	23651 80800	yes	no			Details
polyethyleneglycol 1 - 4.5 moles ethoxylated	500-038-2	25322-68-3	638	23590 76960	yes	no			Details
[3-(methacryloxy)propyl]trimethoxysilane	219-785-8	2530-85-0	788	21498	no	no	0.05 mg/kg	Only to be used as a surface treatment agent of inorganic fillers.	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
dipropyleneglycol	246-770-3	25265-71-8	257	16660 13550 51760	yes	no			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
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no	0.05 mg/kg	SML expressed as acrylic acid, 2-ethylhexyl ester.	Details
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no			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
tert-butyl-4-hydroxyanisole	246-563-8	25013-16-5	635	40720	yes	no	30 mg/kg		Details
dioctadecyl disulphide	219-702-5	2500-88-1	449	49840	yes	yes	0.05 mg/kg		Details
acrylic acid, n-octyl ester	219-696-4	2499-59-4	448	11890	no	no			Details
methacrylic acid, benzyl ester	219-674-4	2495-37-6	447	20080	no	no			Details
acrylic acid, benzyl ester	219-673-9	2495-35-4	446	10750	no	no			Details
ethylene-vinyl acetate copolymer wax	429-840-1	24937-78-8	969		yes	no		Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.	Details
tripropyleneglycol	246-466-0	24800-44-0	634	25910	no	no			Details
pyrophosphoric acid	219-574-0	2466-09-3	445	83440	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
2-(2'-hydroxy-5'-methylphenyl)benzotriazole	219-470-5	2440-22-4	444	61440	yes	no			Details
11-aminoundecanoic acid	219-417-6	2432-99-7	443	12788	no	no	5 mg/kg		Details
1,4-butanediol bis(2,3-epoxypropyl)ether	219-371-7	2425-79-8	442	13780	no	no	0.01 mg/kg	Residual content = 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	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
2,3,6-trimethylphenol	219-330-3	2416-94-6	882	25872	no	no	0.05 mg/kg		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
2-ethoxy-2'-ethyloxanilide	245-950-9	23949-66-8	633	53200	yes	yes	30 mg/kg		Details
4-ethoxybenzoic acid, ethyl ester	245-818-0	23676-09-7	632	52880	yes	no	3.6 mg/kg		Details
benzoic acid, propyl ester	219-020-8	2315-68-6	441	38160	yes	no			Details
1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)	245-442-7	23128-74-7	631	59120	yes	yes	45 mg/kg		Details
1,2-propyleneglycol dilaurate	245-217-3	22788-19-8	630	82240	yes	no			Details
1,3,5-tris(4-benzoylphenyl) benzene	-	227099-60-7	781	95265	yes	no	0.05 mg/kg		Details
methacrylic acid, propyl ester	218-639-0	2210-28-8	440	21340	no	no			Details
methacrylic acid, phenyl ester	218-542-3	2177-70-0	439	21280	no	no			Details

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