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

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Showing 301 - 400 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
2,4-toluene diisocyanate	209-544-5	584-84-9	354	25210	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
carbonic acid, rubidium salt	209-530-9	584-09-8	353	42480	yes	no	12 mg/kg		Details
poly(12-hydroxystearic acid) stearate	500-140-7	58128-22-6	875	80345	yes	yes	5 mg/kg		Details
alpha-tocopherol acetate	200-405-4	58-95-7	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
2,6-dimethylphenol	209-400-1	576-26-1	352	16360	no	no	0.05 mg/kg		Details
dimethyltin bis(ethylhexyl mercaptoacetate)	260-829-0	57583-35-4	698	49595	yes	no			Details
monomethyltin tris(ethylhexyl mercaptoacetate)	260-828-5	57583-34-3	697	67515	yes	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
calcium butyrate	227-265-7	5743-36-2	489	41040	yes	no			Details
1,2-propanediol	200-338-0	57-55-6	109	23740 81840	yes	no			Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
urea	200-315-5	57-13-6	107	25960	no	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	yes	no			Details
palmitic acid	200-312-9	57-10-3	105	22780 70400	yes	no			Details
hexadecyltrimethylammonium bromide	200-311-3	57-09-0	104	58960	yes	no	6 mg/kg		Details
di-n-octyltin ethyleneglycol bis(mercaptoacetate)	260-414-4	56875-68-4	736	50960	yes	no			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
glycerol	200-289-5	56-81-5	103	18100 55920	yes	no			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
lignoceric acid	209-180-7	557-59-5	350	63920	yes	no			Details
trimellitic anhydride	209-008-0	552-30-7	349	25550	no	no			Details
N,N'-ethylenebispalmitamide	226-864-0	5518-18-3	488	53440	yes	no			Details
monomethyltin tris(isooctyl mercaptoacetate)	259-374-0	54849-38-6	695	67520	yes	no			Details
di(p-tolylidene)sorbitol	611-185-8	54686-97-4	752	39890	yes	no			Details
myristic acid	208-875-2	544-63-8	348	67891 22350	yes	no			Details
methacrylic acid, sulphopropyl ester	-	54276-35-6	694	21400	no	no	0.05 mg/kg		Details
sorbitan tripalmitate	258-994-9	54140-20-4	693	88160	yes	no			Details
trimellitic acid	208-432-3	528-44-9	347	25540 13050	no	no			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
2-cyano-3,3-diphenylacrylic acid, ethyl ester	226-029-0	5232-99-5	487	45640	yes	no	0.05 mg/kg		Details
2-(4-dodecylphenyl)indole	257-624-3	52047-59-3	692	52320	yes	yes	0.06 mg/kg		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
abietic acid	208-178-3	514-10-3	346	10030	no	no			Details
ethylene-N-palmitamide-N'-stearamide	-	5136-44-7	486	54005	yes	no			Details
dicyclohexylmethane-4,4'-diisocyanate	225-863-2	5124-30-1	485	15700 13560	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
arachidic acid	208-031-3	506-30-9	345	35840	yes	no			Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no			Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no	0.05 mg/kg		Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no			Details
1,3-propanediol	207-997-3	504-63-2	343	23770	no	no	0.05 mg/kg		Details
caprolactone	207-938-1	502-44-3	342	14260	no	no			Details
glucose	200-075-1	50-99-7	102	17530	no	no			Details
ascorbic acid	200-066-2	50-81-7	101	36000	yes	no			Details
sorbitol	200-061-5	50-70-4	100	88320 24490	yes	no			Details
lactic acid	200-018-0	50-21-5	99	19460 62960	yes	no			Details
formaldehyde	200-001-8	50-00-0	98	17260 54880	yes	no			Details
bicyclo[2.2.1]hept-2-ene	207-866-0	498-66-8	341	22550 13180	no	no	0.05 mg/kg		Details
2,2-bis(hydroxymethyl)propionic acid	225-306-3	4767-03-7	484	13395	no	no	0.05 mg/kg		Details
3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone	256-318-7	47465-97-4	691	13600	no	no	1.8 mg/kg		Details
n-octylphosphonic acid	225-218-5	4724-48-5	483	68860	yes	no	0.05 mg/kg		Details
methacrylic acid, isopropyl ester	225-094-2	4655-34-9	482	21100	no	no			Details
dicyanodiamide	207-312-8	461-58-5	340	47440	yes	no	60 mg/kg		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
1,3,5-benzenetricarboxylic acid trichloride	224-594-8	4422-95-1	481	13060	no	no	0.05 mg/kg	SML expressed as 1,3,5-benzenetricarboxylic acid.	Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide NYLOSTAB S-EED; NYSEED	419-710-0	42774-15-2	1051		yes	no	5 mg/kg		Details
3,5-di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester	224-166-0	4221-80-1	480	46790	yes	no			Details
azelaic anhydride	-	4196-95-6	479	12970	no	no			Details
4-hydroxybenzoic acid, isopropyl ester	224-069-3	4191-73-5	478	60180	yes	no			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
2,6-di-tert-butyl-4-ethylphenol	223-945-2	4130-42-1	477	46720	yes	yes	4.8 mg/kg		Details
diphenylether-4,4'-diisocyanate	626-593-1	4128-73-8	476	16570	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane	223-861-6	4098-71-9	475	19110	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
silicon carbide	206-991-8	409-21-2	339	86160	yes	no			Details
1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride	223-805-0	4080-31-3	474	43600	yes	no	0.3 mg/kg		Details
adipic acid, divinyl ester	223-792-1	4074-90-2	473	12265	no	no	0.01 mg/kg	5 mg/kg in final product. Only to be used as co-monomer.	Details
2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	223-773-8	4066-02-8	472	66560	yes	yes			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
(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
5-sulphoisophthalic acid, monosodium salt, dimethyl ester	223-578-8	3965-55-7	471	24888	no	no	0.05 mg/kg		Details
tungsten oxide	254-413-8	39318-18-8	1064		yes	no	0.05 mg/kg	Stoichiometry: WOn, n = 2,72-2,90.	Details
2-(2'-hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazole	223-445-4	3896-11-5	470	60400	yes	yes			Details
2-(2'-hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole	223-383-8	3864-99-1	469	60480	yes	yes			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
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
2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride)	253-781-7	38103-06-9	687	13614 13530	no	no	0.05 mg/kg		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
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
hydroxymethylcellulose	609-415-7	37353-59-6	686	61390	yes	no			Details
palmitoleic acid	206-765-9	373-49-9	338	71020	yes	no			Details
aluminum calcium oxide sulfate	609-389-7	37293-22-4	598	41600	yes	no			Details
nepheline syenite	609-369-8	37244-96-5	684	68125	yes	no			Details
crotonic acid	223-077-4	3724-65-0	467	45600 14800	yes	no			Details
glycerol, esters with oleic acid	253-407-2	37220-82-9	49	56540	yes	no			Details
methylcarboxymethylcellulose	-	37206-01-2	683	66200	yes	no			Details
ethylcarboxymethylcellulose	-	37205-99-5	682	53270	yes	no			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
1-hexadecanol	253-149-0	36653-82-4	681	18310	no	no			Details
di-n-octyltin dilaurate	222-883-3	3648-18-8	466	50640	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
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
1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane	252-816-3	35958-30-6	679	39060	yes	yes	5 mg/kg		Details
1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)	252-346-9	35074-77-2	678	59200	yes	yes	6 mg/kg		Details
4,4'-difluorobenzophenone	206-466-3	345-92-6	337	15820	no	no	0.05 mg/kg		Details
1,2-propyleneglycol dipalmitate	251-581-4	33587-20-1	677	82560	yes	no			Details
di-n-octyltin bis(isooctyl maleate)	251-576-7	33568-99-9	676	50400	yes	no			Details
n-decanoic acid	206-376-4	334-48-5	336	45940 15095	yes	no			Details
7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin	222-067-7	3333-62-8	465	68040	yes	no			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
2-hydroxy-4-n-hexyloxybenzophenone	-	3293-97-8	464	61280	yes	yes			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

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