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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 101 - 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)
2,2'-dihydroxy-4-methoxybenzophenone	205-026-8	131-53-3	317	48880	yes	yes			Details
2,2'-dihydroxy-5,5'-dichlorodiphenylmethane	202-567-1	97-23-4	179	48800	yes	yes	12 mg/kg		Details
2,2'-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite	403-020-1	118337-09-0	759	54300	yes	yes	6 mg/kg		Details
2,2'-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate	286-344-4	85209-91-2	749	66360	yes	yes	5 mg/kg		Details
2,2'-methylene bis(4-ethyl-6-tert-butylphenol)	201-814-0	88-24-4	163	66400	yes	yes			Details
2,2'-methylene bis(4-methyl-6-tert-butylphenol)	204-327-1	119-47-1	285	66480	yes	yes			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
2,2'-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	201-044-5	77-62-3	137	66580	yes	yes			Details
2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	223-773-8	4066-02-8	472	66560	yes	yes			Details
2,2'-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	274-572-7	70331-94-1	739	70000	yes	no			Details
2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer	-	78301-43-6	742	92700	yes	yes	5 mg/kg		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
2,2,4-trimethyl-1,3-pentanediol diisobutyrate	229-934-9	6846-50-0	497	95020	yes	no	5 mg/kg	Only to be used in single-use gloves.	Details
2,2-bis(4-hydroxyphenyl)propane	201-245-8	80-05-7	151	13480 13607	no	no	0.05 mg/kg	Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union]. Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].	Details
2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether	216-823-5	1675-54-3	426	13610 13510	no	no		In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].	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
2,2-bis(hydroxymethyl)propionic acid	225-306-3	4767-03-7	484	13395	no	no	0.05 mg/kg		Details
2,2-dimethyl-1,3-propanediol	204-781-0	126-30-7	310	16390 22437	no	no	0.05 mg/kg		Details
2,3,3,4,4,5,5-heptafluoro-1-pentene	-	1547-26-8	1063		no	no		Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.	Details
2,3,6-trimethylphenol	219-330-3	2416-94-6	882	25872	no	no	0.05 mg/kg		Details
2,4,4'-trifluorobenzophenone	813-638-7	80512-44-3	1061		no	no		Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.	Details
2,4,6-triamino-1,3,5-triazine	203-615-4	108-78-1	239	25420 19975 93720	yes	no	2.5 mg/kg		Details
2,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite	423-560-1	161717-32-4	774	95270	yes	yes	2 mg/kg	SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP.	Details
2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl-(''SPG'')	604-479-2	1455-42-1	1052		no	no	5 mg/kg	Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).	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
2,4-bis(dodecylthiomethyl)-6-methylphenol	438-600-3	110675-26-8	758	38940	yes	yes			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
2,4-bis(octylthiomethyl)-6-methylphenol CG 25-1320; IRGANOX 1520; TK 12229/1	402-860-6	110553-27-0	756	40020	yes	yes			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
2,4-diamino-6-phenyl-1,3,5-triazine	202-095-6	91-76-9	168	13075 15310	no	no	5 mg/kg		Details
2,4-dihydroxybenzophenone	205-029-4	131-56-6	318	48640	yes	no			Details
2,4-dimethyl-6-(1-methylpentadecyl)phenol CG 27-145	411-220-5	134701-20-5	765	49485	yes	yes	1 mg/kg		Details
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
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
2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene	230-426-4	7128-64-5	500	38560	yes	yes	0.6 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
2,6-di-tert-butyl-p-cresol	204-881-4	128-37-0	315	46640	yes	no	3 mg/kg		Details
2,6-dimethylphenol	209-400-1	576-26-1	352	16360	no	no	0.05 mg/kg		Details
2,6-naphthalenedicarboxylic acid	214-527-0	1141-38-4	389	22360	no	no	5 mg/kg		Details
2,6-naphthalenedicarboxylic acid, dimethyl ester	212-661-4	840-65-3	373	22390	no	no	0.05 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
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
2-(2'-hydroxy-5'-methylphenyl)benzotriazole	219-470-5	2440-22-4	444	61440	yes	no			Details
2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol CG 30-1577	411-380-6	147315-50-2	770	51700	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
2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole	274-570-6	70321-86-7	738	60320	yes	yes	1.5 mg/kg		Details
2-acrylamido-2-methylpropanesulphonic acid	239-268-0	15214-89-8	617	10660	no	no	0.05 mg/kg		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-aminoethanol	205-483-3	141-43-5	326	35170 12763	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. For indirect food contact only, behind a PET layer.	Details
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

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