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

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Showing 151 - 200 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-butene	203-452-9	107-01-7	224	13900	no	no			Details
2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester	228-250-8	6197-30-4	492	45650	yes	no	0.05 mg/kg		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-ethoxy-2'-ethyloxanilide	245-950-9	23949-66-8	633	53200	yes	yes	30 mg/kg		Details
2-ethyl-1-hexanol	203-234-3	104-76-7	209	17050	no	no	30 mg/kg		Details
2-hydroxy-4-methoxybenzophenone	205-031-5	131-57-7	319	61360	yes	yes			Details
2-hydroxy-4-n-hexyloxybenzophenone	-	3293-97-8	464	61280	yes	yes			Details
2-hydroxy-4-n-octyloxybenzophenone	217-421-2	1843-05-6	431	61600	yes	yes			Details
2-methyl-1,3-butadiene	201-143-3	78-79-5	144	21640 19243	no	no	0.01 mg/kg	1 mg/kg in final product.	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
2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine	455-890-7	6607-41-6	872		no	no	0.05 mg/kg	To be used only as a co-monomer in polycarbonate copolymers.	Details
2-phenylindole	213-436-3	948-65-2	383	72160	yes	yes	15 mg/kg		Details
2-propanol	200-661-7	67-63-0	118	81882 23830	yes	no			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
3,3',5,5'-tetrakis(tert-butyl)-2,2'-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid	-	203255-81-6	792	92475	yes	yes	5 mg/kg	SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products.	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
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
3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone	256-318-7	47465-97-4	691	13600	no	no	1.8 mg/kg		Details
3,3-bis(methoxymethyl)-2,5-dimethylhexane	430-800-9	129228-21-3	763	39925	yes	yes	0.05 mg/kg		Details
3,4-diacetoxy-1-butene 3,4-DIACETOXY-1-BUTENE	421-720-5	18085-02-4	862	15180	no	no	0.05 mg/kg	SML including the hydrolysis product 3,4- dihydroxy-1-butene. Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.	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
3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester	267-342-2	67845-93-6	721	46800	yes	no			Details
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester	221-532-1	3135-18-0	459	46870	yes	no			Details
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt	265-512-0	65140-91-2	715	46880	yes	no	6 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
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
3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether	236-946-8	13560-49-1	611	35120	yes	no			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
3-buten-2-ol	209-929-8	598-32-3	357	13932	no	no	0.01 mg/kg	Only to be used as a co-monomer for the preparation of polymeric additive.	Details
3-chlorophthalic anhydride	204-179-8	117-21-5	786	14627	no	no	0.05 mg/kg	SML expressed as 3-chlorophthalic acid.	Details
3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer	616-996-0	80181-31-3	744	18888	no	no		The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.	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
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
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
4,4'-bis(2-benzoxazolyl)stilbene	216-245-3	1533-45-5	422	38515	yes	yes	0.05 mg/kg		Details
4,4'-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)	235-841-4	13003-12-8	608	40800	yes	yes	6 mg/kg		Details
4,4'-diaminodiphenyl sulphone	201-248-4	80-08-0	153	15267	no	no	5 mg/kg		Details
4,4'-dichlorodiphenyl sulphone	201-247-9	80-07-9	152	15610	no	no	0.05 mg/kg		Details
4,4'-difluorobenzophenone	206-466-3	345-92-6	337	15820	no	no	0.05 mg/kg		Details
4,4'-dihydroxybenzophenone	210-288-1	611-99-4	359	15970 48720	yes	no			Details
4,4'-dihydroxybiphenyl	202-200-5	92-88-6	170	16000	no	no	6 mg/kg		Details
4,4'-dihydroxydiphenyl sulphone	201-250-5	80-09-1	154	13617 16090	no	no	0.05 mg/kg		Details
4,4'-methylenebis(3-chloro-2,6-diethylaniline)	402-130-7	106246-33-7	755	21765	no	no	0.05 mg/kg		Details
4,4'-oxybis(benzenesulphonyl azide)	431-850-4	7456-68-0	502	22778	no	no	0.05 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
4-(hydroxymethyl)-1-cyclohexene	216-847-6	1679-51-2	427	18896	no	no	0.05 mg/kg		Details
4-chlorophthalic anhydride	204-251-9	118-45-6	787	14628	no	no	0.05 mg/kg	SML expressed as 4-chlorophthalic acid.	Details
4-cumylphenol	209-968-0	599-64-4	358	14841	no	no	0.05 mg/kg		Details
4-ethoxybenzoic acid, ethyl ester	245-818-0	23676-09-7	632	52880	yes	no	3.6 mg/kg		Details
4-hydroxybenzoic acid, ethyl ester	204-399-4	120-47-8	287	60160	yes	no			Details

Showing 151 - 200 of 1,080 results.

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