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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 1 - 50 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

Showing 1 - 50 of 1,080 results.

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