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

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Showing 301 - 400 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'-methylene bis(4-methyl-6-tert-butylphenol)	204-327-1	119-47-1	285	66480	yes	yes			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-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
2,4,6-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(dodecylthiomethyl)-6-methylphenol	438-600-3	110675-26-8	758	38940	yes	yes			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-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
2,6-di-tert-butyl-p-cresol	204-881-4	128-37-0	315	46640	yes	no	3 mg/kg		Details
2,6-naphthalenedicarboxylic acid	214-527-0	1141-38-4	389	22360	no	no	5 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-acrylamido-2-methylpropanesulphonic acid	239-268-0	15214-89-8	617	10660	no	no	0.05 mg/kg		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-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-octyloxybenzophenone	217-421-2	1843-05-6	431	61600	yes	yes			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-(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-chlorophthalic anhydride	204-179-8	117-21-5	786	14627	no	no	0.05 mg/kg	SML expressed as 3-chlorophthalic acid.	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'-methylenebis(3-chloro-2,6-diethylaniline)	402-130-7	106246-33-7	755	21765	no	no	0.05 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-hydroxybenzoic acid, ethyl ester	204-399-4	120-47-8	287	60160	yes	no			Details
5-ethylidenebicyclo[2,2,1]hept-2-ene	240-347-7	16219-75-3	621	17110	no	no	0.05 mg/kg		Details
6-hydroxy-2-naphthalenecarboxylic acid	240-759-7	16712-64-4	624	18897	no	no	0.05 mg/kg		Details
9,10-dihydroxy stearic acid	204-432-2	120-87-6	27	48960	yes	no	5 mg/kg		Details
9,9-bis(methoxymethyl)fluorene	682-678-3	182121-12-6	779	39815	yes	yes	0.05 mg/kg		Details
acetic acid, butyl ester	204-658-1	123-86-4	300	30045	yes	no			Details
acetic acid, ethyl ester	205-500-4	141-78-6	327	30140	yes	no			Details
acetic acid, vinyl ester	203-545-4	108-05-4	231	10120	no	no	12 mg/kg		Details
acetic anhydride	203-564-8	108-24-7	232	30280 10150	yes	no			Details
acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester SUMILIZER GS	413-850-6	123968-25-2	762	31530	yes	yes	5 mg/kg		Details
acrylic acid, 2-ethylhexyl ester	203-080-7	103-11-7	206	11500	no	no	0.05 mg/kg		Details
acrylic acid, dicyclopentenyl ester	235-697-2	12542-30-2	605	11005	no	no	0.05 mg/kg		Details
acrylic acid, ethyl ester	205-438-8	140-88-5	323	11470	no	no			Details
acrylic acid, isobutyl ester	203-417-8	106-63-8	218	11590	no	no			Details
acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters	-	174254-23-0	777	31542	yes	no		0,5 % in final product.	Details
acrylic acid, n-butyl ester	205-480-7	141-32-2	325	10780	no	no			Details
acrylic acid, tert-butyl ester	216-768-7	1663-39-4	425	10840	no	no			Details
acrylonitrile	203-466-5	107-13-1	225	12100	no	no	0.01 mg/kg		Details
adipic acid	204-673-3	124-04-9	303	31730 12130	yes	no			Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes	18 mg/kg		Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes			Details
alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated	604-520-4	146340-15-0	802	33105	yes	no	5 mg/kg		Details
aluminium calcium hydroxide phosphite, hydrate	-	191427-79-9	18	34475	yes	no			Details
aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate]	430-650-4	151841-65-5	771	34650	yes	no	5 mg/kg		Details
aluminium magnesium carbonate hydroxide	234-319-3	11097-59-9	592	34690	yes	no			Details
aluminium oxide	215-691-6	1344-28-1	418	34720	yes	no			Details
amines, bis(hydrogenated tallow alkyl) oxidised	418-370-0	143925-92-2	768	34850	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.	Details
ammonium bromide	235-183-8	12124-97-9	601	35440	yes	no			Details
ammonium hydroxide	215-647-6	1336-21-6	413	35600	yes	no			Details
antimony trioxide	215-175-0	1309-64-4	398	35760	yes	no			Details
ascorbyl palmitate	205-305-4	137-66-6	321	36080	yes	no			Details
ascorbyl stearate	234-231-5	10605-09-1	591	36160	yes	no			Details
azelaic acid	204-669-1	123-99-9	302	12820	no	no			Details
barium hydroxide	241-234-5	17194-00-2	625	36720	yes	no			Details
barium nitrate	233-020-5	10022-31-8	581	36800	yes	no			Details
barium tetraborate	-	12007-55-5	599	36840	yes	no			Details
behenic acid	204-010-8	112-85-6	272	37040	yes	no			Details
bentonite A colloidal clay. Consists primarily of montmorillonite.	215-108-5	1302-78-9	393	37280	yes	no			Details
benzaldehyde	202-860-4	100-52-7	195	37360	yes	no			Details
benzoic acid, butyl ester	205-252-7	136-60-7	320	37680	yes	no			Details
benzophenone	204-337-6	119-61-9	286	38240	yes	yes	0.6 mg/kg		Details
benzyl alcohol	202-859-9	100-51-6	194	13150	no	no			Details
bis(2,4-dicumylphenyl)pentaerythritol-diphosphite	421-920-2	154862-43-8	773	38840	yes	yes	5 mg/kg	SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol).	Details
bis(3,4-dimethylbenzylidene)sorbitol	413-110-2	135861-56-2	766	38879	yes	no			Details
bis(4-aminocyclohexyl)methane	217-168-8	1761-71-3	429	13210	no	no	0.05 mg/kg		Details
boric acid	233-139-2	10043-35-3	584	40320 13620	yes	no			Details
boron nitride	233-136-6	10043-11-5	583	40400	yes	no			Details
butadiene	203-450-8	106-99-0	223	13630	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
butane	203-448-7	106-97-8	221	40570	yes	no			Details
butyraldehyde	204-646-6	123-72-8	298	14110	no	no			Details
butyric acid	203-532-3	107-92-6	229	14140	no	no			Details
butyric anhydride	203-383-4	106-31-0	215	14170	no	no			Details
calcium chloride	233-140-8	10043-52-4	585	41120	yes	no			Details
calcium hydroxide	215-137-3	1305-62-0	394	41280	yes	no			Details
calcium oxide	215-138-9	1305-78-8	395	41520	yes	no			Details
caprolactam	203-313-2	105-60-2	212	41840 14200	yes	no			Details
caprylic acid	204-677-5	124-07-2	304	14320 41960	yes	no			Details
carbon black	215-609-9	1333-86-4	411	42080	yes	no		Primary particles of 10 - 300 nm which are aggregated to a size of 100 - 1200 nm which may form agglomerates within the size distribution of 300 nm - mm. Toluene extractables: maximum 0,1 %, determined according to ISO method 6209. UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis. Benzo(a)pyrene content: max 0,25 mg/kg carbon black. Maximum use level of carbon black in the polymer: 2,5 % w/w.	Details
carbon dioxide	204-696-9	124-38-9	307	42160	yes	no			Details
cis-11-eicosenamide	-	10436-08-5	589	52645	yes	no			Details
cobalt oxide	234-334-5	11104-61-3	593	44960	yes	no			Details
copper hydroxide phosphate	235-285-2	12158-74-6	972	45197	yes	no			Details
copper iodide	215-625-6	1335-23-5	412	45200	yes	no			Details
cristobalite	238-455-4	14464-46-1	614	45560	yes	no			Details
cyclohexylamine	203-629-0	108-91-8	240	45760	yes	no			Details
di-n-octyltin bis(2-ethylhexyl maleate)	233-117-2	10039-33-5	582	50240	yes	no			Details
di-n-octyltin bis(2-ethylhexyl mercaptoacetate)	239-622-4	15571-58-1	619	50320	yes	no			Details
di-n-octyltin dimaleate	239-625-0	15571-60-5	620	50720	yes	no			Details
di-n-octyltin mercaptoacetate	239-581-2	15535-79-2	618	51040	yes	no			Details
diethyleneglycol	203-872-2	111-46-6	263	47680 13326 15760	yes	no			Details

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