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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 901 - 1,000 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
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-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-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-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether	236-946-8	13560-49-1	611	35120	yes	no			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
3,9-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
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt	265-512-0	65140-91-2	715	46880	yes	no	6 mg/kg		Details
3,5-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-hydroxybenzoic acid, hexadecyl ester	267-342-2	67845-93-6	721	46800	yes	no			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
3,4-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
3,3-bis(methoxymethyl)-2,5-dimethylhexane	430-800-9	129228-21-3	763	39925	yes	yes	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
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'-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',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
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
2-propanol	200-661-7	67-63-0	118	81882 23830	yes	no			Details
2-phenylindole	213-436-3	948-65-2	383	72160	yes	yes	15 mg/kg		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-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-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-hydroxy-4-n-octyloxybenzophenone	217-421-2	1843-05-6	431	61600	yes	yes			Details
2-hydroxy-4-n-hexyloxybenzophenone	-	3293-97-8	464	61280	yes	yes			Details
2-hydroxy-4-methoxybenzophenone	205-031-5	131-57-7	319	61360	yes	yes			Details
2-ethyl-1-hexanol	203-234-3	104-76-7	209	17050	no	no	30 mg/kg		Details
2-ethoxy-2'-ethyloxanilide	245-950-9	23949-66-8	633	53200	yes	yes	30 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-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester	228-250-8	6197-30-4	492	45650	yes	no	0.05 mg/kg		Details
2-butene	203-452-9	107-01-7	224	13900	no	no			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-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-acrylamido-2-methylpropanesulphonic acid	239-268-0	15214-89-8	617	10660	no	no	0.05 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-(4-dodecylphenyl)indole	257-624-3	52047-59-3	692	52320	yes	yes	0.06 mg/kg		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-(2'-hydroxy-5'-methylphenyl)benzotriazole	219-470-5	2440-22-4	444	61440	yes	no			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-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazole	223-445-4	3896-11-5	470	60400	yes	yes			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
2,6-naphthalenedicarboxylic acid, dimethyl ester	212-661-4	840-65-3	373	22390	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-dimethylphenol	209-400-1	576-26-1	352	16360	no	no	0.05 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-di-tert-butyl-4-ethylphenol	223-945-2	4130-42-1	477	46720	yes	yes	4.8 mg/kg		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
2,4-toluene diisocyanate dimer	247-953-0	26747-90-0	653	25270	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
2,4-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-dimethyl-6-(1-methylpentadecyl)phenol CG 27-145	411-220-5	134701-20-5	765	49485	yes	yes	1 mg/kg		Details
2,4-dihydroxybenzophenone	205-029-4	131-56-6	318	48640	yes	no			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-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-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-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(dodecylthiomethyl)-6-methylphenol	438-600-3	110675-26-8	758	38940	yes	yes			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
2,4,8,10-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
2,4,6-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
2,4,6-triamino-1,3,5-triazine	203-615-4	108-78-1	239	25420 19975 93720	yes	no	2.5 mg/kg		Details
2,4,4'-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
2,3,6-trimethylphenol	219-330-3	2416-94-6	882	25872	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
2,2-dimethyl-1,3-propanediol	204-781-0	126-30-7	310	16390 22437	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-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(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	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
2,2,4-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
2,2,4,4-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
2,2,4,4-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'-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	274-572-7	70331-94-1	739	70000	yes	no			Details
2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	223-773-8	4066-02-8	472	66560	yes	yes			Details
2,2'-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	201-044-5	77-62-3	137	66580	yes	yes			Details
2,2'-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate	617-688-9	85209-93-4	750	66350	yes	no	5 mg/kg		Details
2,2'-methylene bis(4-methyl-6-tert-butylphenol)	204-327-1	119-47-1	285	66480	yes	yes			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(4,6-di-tert-butylphenyl) sodium phosphate	286-344-4	85209-91-2	749	66360	yes	yes	5 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'-dihydroxy-5,5'-dichlorodiphenylmethane	202-567-1	97-23-4	179	48800	yes	yes	12 mg/kg		Details
2,2'-dihydroxy-4-methoxybenzophenone	205-026-8	131-53-3	317	48880	yes	yes			Details
2,2'-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one] CYASORB(R) UV-3638 LIGHT STABILISER	418-280-1	18600-59-4	796	72141	yes	yes	0.05 mg/kg	SML including the sum of its hydrolysis products.	Details
2,2',2'-nitrilo(triethyl tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite)	279-459-6	80410-33-9	745	68145	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	Details
12-hydroxystearic acid	203-366-1	106-14-9	214	61840	yes	no			Details
12-aminododecanoic acid	211-754-7	693-57-2	369	12761	no	no	0.05 mg/kg		Details
11-aminoundecanoic acid	219-417-6	2432-99-7	443	12788	no	no	5 mg/kg		Details
1-vinylimidazole	214-012-0	1072-63-5	387	26155	no	no	0.05 mg/kg		Details
1-tetradecene	214-306-9	1120-36-1	388	25080	no	no	0.05 mg/kg		Details
1-propanol	200-746-9	71-23-8	122	23800	no	no			Details
1-pentene	203-694-5	109-67-1	245	22900	no	no	5 mg/kg		Details
1-pentanol	200-752-1	71-41-0	124	22870	no	no			Details
1-octene	203-893-7	111-66-0	264	22660	no	no	15 mg/kg		Details
1-octanol	203-917-6	111-87-5	265	22600	no	no			Details
1-nonanol	205-583-7	143-08-8	331	22480	no	no			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
1-hexene	209-753-1	592-41-6	356	18820	no	no	3 mg/kg		Details
1-hexadecanol	253-149-0	36653-82-4	681	18310	no	no			Details
1-dodecene	203-968-4	112-41-4	268	16704	no	no	0.05 mg/kg		Details
1-decene	212-819-2	872-05-9	375	15130	no	no	0.05 mg/kg		Details
1-decanol	203-956-9	112-30-1	267	15100	no	no			Details
1-butene	203-449-2	106-98-9	222	13870	no	no			Details

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