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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 - 100 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
acrylic acid, 2-hydroxypropyl ester	213-663-8	999-61-1	385	11530	no	no	0.05 mg/kg	SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).	Details
glycerol dibehenate	-	99880-64-5	754	56020	yes	no			Details
2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine	213-590-1	991-84-4	384	40000	yes	yes	30 mg/kg		Details
p-hydroxybenzoic acid	202-804-9	99-96-7	190	18880	no	no			Details
4-hydroxybenzoic acid, methyl ester	202-785-7	99-76-3	189	60200	yes	no			Details
isophthalic acid dichloride	202-774-7	99-63-8	188	19180	no	no			Details
α-methylstyrene	202-705-0	98-83-9	187	22210	no	no	0.05 mg/kg		Details
4-tert-butylphenol	202-679-0	98-54-4	186	14020	no	no	0.05 mg/kg		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
methacrylic acid, diester with ethyleneglycol	202-617-2	97-90-5	185	20440	no	no	0.05 mg/kg		Details
methacrylic acid, butyl ester	202-615-1	97-88-1	184	20110	no	no			Details
methacrylic acid, isobutyl ester	202-613-0	97-86-9	183	21010	no	no			Details
itaconic acid	202-599-6	97-65-4	182	19270	no	no			Details
methacrylic acid, ethyl ester	202-597-5	97-63-2	181	20890	no	no			Details
eugenol	202-589-1	97-53-0	180	17160	no	no			Details
2,2'-dihydroxy-5,5'-dichlorodiphenylmethane	202-567-1	97-23-4	179	48800	yes	yes	12 mg/kg		Details
4,4'-thiobis(6-tert-butyl-3-methylphenol)	202-525-2	96-69-5	178	92800	yes	yes	0.48 mg/kg		Details
ethylene carbonate	202-510-0	96-49-1	177	16955	no	no	30 mg/kg	SML expressed as ethyleneglycol. Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.	Details
acrylic acid, methyl ester	202-500-6	96-33-3	176	11710	no	no			Details
methacrylic acid, allyl ester	202-473-0	96-05-9	175	20050	no	no	0.05 mg/kg		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
o-cresol	202-423-8	95-48-7	174	14740	no	no			Details
2-phenylindole	213-436-3	948-65-2	383	72160	yes	yes	15 mg/kg		Details
laurolactam	213-424-8	947-04-6	382	19490	no	no	5 mg/kg		Details
4-hydroxybenzoic acid, propyl ester	202-307-7	94-13-3	173	60240	yes	no			Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	10 mg/kg	SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.	Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	1 mg/kg	The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/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
benzoic acid, ethyl ester	202-284-3	93-89-0	172	37840	yes	no			Details
benzoic acid, methyl ester	202-259-7	93-58-3	171	38080	yes	no			Details
kaolin, calcined The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.	296-473-8	92704-41-1	753	62800	yes	no			Details
acrylic acid, propyl ester	213-120-5	925-60-0	380	11980	no	no			Details
N-methylolacrylamide	213-103-2	924-42-5	379	21940	no	no	0.01 mg/kg		Details
N-methylolmethacrylamide	213-086-1	923-02-4	378	21970	no	no	0.05 mg/kg		Details
4,4'-dihydroxybiphenyl	202-200-5	92-88-6	170	16000	no	no	6 mg/kg		Details
3-aminopropyltriethoxysilane	213-048-4	919-30-2	377	12786	no	no	0.05 mg/kg	Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers. SML = 0,05 mg/kg when used for the surface treatment of materials and articles.	Details
alkyl(C10-C21)sulphonic acid, esters with phenol	293-728-5	91082-17-6	884	34240	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
3,3'-dimethyl-4,4'-diisocyanatobiphenyl	202-112-7	91-97-4	169	16240	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
2,4-diamino-6-phenyl-1,3,5-triazine	202-095-6	91-76-9	168	13075 15310	no	no	5 mg/kg		Details
2,6-toluene diisocyanate	202-039-0	91-08-7	167	25240	no	no		1 mg/kg in final product expressed as isocyanate moiety.	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
poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] hexa-methylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]	-	90751-07-8	790	80480	yes	no	5 mg/kg	Average molecular weight not less than 2400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.	Details
3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5] undecane ADK STAB AO 80; SUMILIZER GA-80	410-730-5	90498-90-1	858	38565	yes	yes	0.05 mg/kg	SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer.	Details
hydroxypropyl starch	618-565-2	9049-76-7	579	61800	yes	no			Details
polyethyleneglycol tridecyl ether phosphate	618-558-4	9046-01-9	578	79600	yes	no	5 mg/kg	For materials and articles intended for contact with aqueous foods only. Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.	Details
isobutylene-butene copolymer	695-178-5	9044-17-1	577	62280	yes	no			Details
hydroxyethylmethylcellulose	618-528-0	9032-42-2	576	60880	yes	no			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
rubber, natural	232-689-0	9006-04-6	574	84560 24250	yes	no			Details
polyethyleneglycol sorbitan tristearate	618-424-5	9005-71-4	573	79440	yes	no			Details
polyethyleneglycol sorbitan trioleate	618-422-4	9005-70-3	572	79360	yes	no			Details
polyethyleneglycol sorbitan monostearate 1 - 6.5 moles ethoxylated	500-020-4	9005-67-8	571	79280	yes	no			Details
polyethyleneglycol sorbitan monopalmitate	618-421-9	9005-66-7	570	79200	yes	no			Details
polyethyleneglycol sorbitan monooleate 1 - 6.5 moles ethoxylated	500-019-9	9005-65-6	569	79120	yes	no			Details
polyethyleneglycol sorbitan monolaurate 1 - 6.5 moles ethoxylated	500-018-3	9005-64-5	568	79040	yes	no			Details
1,2-propyleneglycol alginate	618-414-0	9005-37-2	567	82080	yes	no			Details
alginic acid	232-680-1	9005-32-7	566	33350	yes	no			Details
hydroxyethyl starch	618-410-9	9005-27-0	565	61120	yes	no			Details
starch, edible High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.	232-679-6	9005-25-8	564	24540 88800	yes	no			Details
polyethyleneglycol monoricinoleate	618-404-6	9004-97-1	563	78320	yes	yes	42 mg/kg		Details
nitrocellulose	618-392-2	9004-70-0	562	22450	no	no			Details
methylcellulose	618-391-7	9004-67-5	561	66240	yes	no			Details
methylhydroxypropylcellulose	618-389-6	9004-65-3	560	66700	yes	no			Details
hydroxypropylcellulose	618-388-0	9004-64-2	559	61680	yes	no			Details
hydroxyethylcellulose	618-387-5	9004-62-0	558	60560	yes	no			Details
methylethylcellulose	-	9004-59-5	557	66640	yes	no			Details
ethylhydroxyethylcellulose	618-385-4	9004-58-4	556	54260	yes	no			Details
ethylcellulose	618-384-9	9004-57-3	555	53280	yes	no			Details
cellulose acetate butyrate	618-381-2	9004-36-8	554	43300	yes	no			Details
cellulose	232-674-9	9004-34-6	553	43280 14500	yes	no			Details
polyvinylpyrrolidone	618-363-4	9003-39-8	552	81500	yes	no		The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC [OJ L 253, 20.9.2008, p. 1.].	Details
Oxirane, 2-methyl-, polymer with oxirane	618-355-0	9003-11-6	551	79920	yes	no			Details
polypropylene wax	618-352-4	9003-07-0	550	81060	yes	no			Details
polyethylene wax	618-339-3	9002-88-4	549	80000	yes	no			Details
casein A complex combination produced in mammary tissue from amino acids supplied by the blood. It contains several proteins, phosphorus, and calcium	232-555-1	9000-71-9	548	42800	yes	no			Details
gelatin A complex combination of proteins obtained by hydrolysis of collagen by boiling skin, tendons, ligaments, bones, etc.	232-554-6	9000-70-8	547	55440	yes	no			Details
pectin	232-553-0	9000-69-5	546	71440	yes	no			Details
tragacanth gum	232-552-5	9000-65-1	545	93680	yes	no			Details
guar gum	232-536-8	9000-30-0	544	58400	yes	no			Details
dammar Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Shorea, Dipterocarpaceae).	232-528-4	9000-16-2	543	45920	yes	no			Details
carboxymethylcellulose	618-326-2	9000-11-7	542	42640	yes	no			Details
gum arabic	232-519-5	9000-01-5	541	58480	yes	no			Details
pyromellitic anhydride	201-898-9	89-32-7	166	24057	no	no	0.05 mg/kg		Details
bis(4-propylbenzylidene)propylsorbitol	618-128-6	882073-43-0	808	38550	yes	no	5 mg/kg	SML including the sum of its hydrolysis products.	Details
phthalic acid	201-873-2	88-99-3	192	23187	no	no			Details
phthalic acid	201-873-2	88-99-3	165	23200 74480	yes	no			Details
2-aminobenzamide	201-851-2	88-68-6	164	34895	yes	no	0.05 mg/kg	Only for use in PET for water and beverages.	Details
2,2'-methylene bis(4-ethyl-6-tert-butylphenol)	201-814-0	88-24-4	163	66400	yes	yes			Details
bis(methylbenzylidene)sorbitol CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005	402-950-5	87826-41-3	752	39890	yes	no			Details
N-methylpyrrolidone	212-828-1	872-50-4	376	66905	yes	no	60 mg/kg		Details
1-decene	212-819-2	872-05-9	375	15130	no	no	0.05 mg/kg		Details
poly(zinc glycerolate)	700-107-9	87189-25-1	751	81515	yes	no			Details
mannitol	201-770-2	87-78-5	162	65520	yes	no			Details
L-(+)-tartaric acid	201-766-0	87-69-4	161	92160	yes	no			Details
salicylic acid, 4-tert-butylphenyl ester	201-728-3	87-18-3	160	84800	yes	yes	12 mg/kg		Details
methacrylic acid, monoester with ethyleneglycol	212-782-2	868-77-9	374	21190	no	no			Details
triethyl phosphonoacetate	212-757-6	867-13-0	800	94425	yes	no		Only for use in PET.	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
N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione	-	852282-89-4	809	49080	yes	yes	0.05 mg/kg	Only for use in PET.	Details
2,2'-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate	617-688-9	85209-93-4	750	66350	yes	no	5 mg/kg		Details

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