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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 401 - 500 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Sorbitol	-	-	100	88320 24490	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Stearic acid	-	-	106	24550 89040	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Styrenesuphonic acid	-	-	656	24760	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Succinic acid	-	-	247	90960 24820	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Sulphuric acid	-	-	511	91920	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Tannic acids	-	-	419	92150	yes	no		According to the JECFA specifications.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Terephthalic acid	-	-	785	24910	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Tetraethyleneglycol	-	-	269	92350 25090	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Tricyclodecanedimethanol	-	-	655	25450	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Triethyleneglycol	-	-	266	25510 94320	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Trimellitic acid	-	-	347	25540 13050	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of α-Tocopherol	-	-	110	93520	yes	no			Details
alpha-tocopherol	200-412-2	59-02-9	110	93520	yes	no			Details
alpha-tocopherol acetate	200-405-4	58-95-7	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
aluminium calcium hydroxide phosphite, hydrate	-	191427-79-9	18	34475	yes	no			Details
aluminium fibers, flakes and powders	-	-	501	34480	yes	no			Details
aluminium hydroxide	244-492-7	21645-51-2	629	34560	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
aluminum calcium oxide sulfate	609-389-7	37293-22-4	598	41600	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
ammonia	231-635-3	7664-41-7	510	12789 35320	yes	no			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
arachidic acid	208-031-3	506-30-9	345	35840	yes	no			Details
arachidonic acid	-	7771-44-0	518	35845	yes	no			Details
ascorbic acid	200-066-2	50-81-7	101	36000	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
azelaic anhydride	-	4196-95-6	479	12970	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
beeswax The wax obtained from the honeycomb of the bee. It consists primarily of myricyl palmitate, cerotic acid and esters and some high-carbon paraffins.	232-383-7	8012-89-3	531	36880	yes	no			Details
behenamide	221-304-1	3061-75-4	458	36960	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	200-618-2	65-85-0	116	37600 13090	yes	no			Details
benzoic acid, butyl ester	205-252-7	136-60-7	320	37680	yes	no			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
benzoic acid, propyl ester	219-020-8	2315-68-6	441	38160	yes	no			Details
benzophenone	204-337-6	119-61-9	286	38240	yes	yes	0.6 mg/kg		Details
Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (BTDA)	219-348-1	2421-28-5	1083		no	no	0.05 mg/kg	Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.	Details
benzyl alcohol	202-859-9	100-51-6	194	13150	no	no			Details
bicyclo[2.2.1]hept-2-ene	207-866-0	498-66-8	341	22550 13180	no	no	0.05 mg/kg		Details
bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	247-952-5	26741-53-7	652	38820	yes	yes	0.6 mg/kg		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(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite ADK STAB PEP-36	410-290-4	80693-00-1	746	38810	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	Details
bis(2,6-diisopropylphenyl) carbodiimide	218-487-5	2162-74-5	438	13303	no	no	0.05 mg/kg	Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline	Details
bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)	264-122-8	63397-60-4	710	38700	yes	yes	18 mg/kg		Details
bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH)	283-829-2	84731-70-4	1079		yes	no	0.05 mg/kg	Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.	Details
bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride	228-253-4	6200-40-4	493	39200	yes	no	1.8 mg/kg		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
bis(4-ethylbenzylidene)sorbitol NC-4	406-176-9	79072-96-1	743	38950	yes	no			Details
bis(4-propylbenzylidene)propylsorbitol	618-128-6	882073-43-0	808	38550	yes	no	5 mg/kg	SML including the sum of its hydrolysis products.	Details
bis(methylbenzylidene)sorbitol	-	69158-41-4	752	39890	yes	no			Details
bis(methylbenzylidene)sorbitol CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005	402-950-5	87826-41-3	752	39890	yes	no			Details
bis(polyethyleneglycol)hydroxymethylphosphonate	614-830-1	68951-50-8	735	40120	yes	no	0.6 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 butyrate	227-265-7	5743-36-2	489	41040	yes	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
camphor	200-945-0	76-22-2	136	41680	yes	no			Details
candelilla wax The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.	232-347-0	8006-44-8	530	41760	yes	no			Details
caprolactam	203-313-2	105-60-2	212	41840 14200	yes	no			Details
caprolactam, sodium salt	218-336-3	2123-24-2	435	14230	no	no			Details
caprolactone	207-938-1	502-44-3	342	14260	no	no			Details
caprylic acid	204-677-5	124-07-2	304	14320 41960	yes	no			Details
carbon	231-153-3	7440-44-0	713	43480	yes	no		Only for use in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).	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
carbon monoxide	211-128-3	630-08-0	362	14350	no	no			Details
carbonic acid, rubidium salt	209-530-9	584-09-8	353	42480	yes	no	12 mg/kg		Details
carbonic acid, salts	-	-	21	42500	yes	no			Details
carbonyl chloride	200-870-3	75-44-5	133	23155 14380	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
carboxymethylcellulose	618-326-2	9000-11-7	542	42640	yes	no			Details
carnauba wax The wax derived from Copernicia cerifera, Palmae.	232-399-4	8015-86-9	533	42720	yes	no			Details
casein A complex combination produced in mammary tissue from amino acids supplied by the blood. It contains several proteins, phosphorus, and calcium	232-555-1	9000-71-9	548	42800	yes	no			Details
castor oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic. (Ricinus communis, Euphorbiaceae).	232-293-8	8001-79-4	527	42880 14411	yes	no			Details
castor oil, dehydrated	264-705-7	64147-40-6	712	42960	yes	no			Details
castor oil, mono- and diglycerides	-	-	22	43200	yes	no			Details
cellulose	232-674-9	9004-34-6	553	43280 14500	yes	no			Details
cellulose acetate butyrate	618-381-2	9004-36-8	554	43300	yes	no			Details
cellulose, regenerated The product obtained by treating cellulose with caustic soda, reacting this with carbon disulfide, dissolving this in a dilute alkali solution and extruding into an acid to form a continuous viscose tube.	270-493-7	68442-85-3	727	43360	yes	no			Details
ceresin A complex combination of hydrocarbons produced by the purification of ozocerite with sulfuric acid and filtration through bone black to form waxy cakes.	232-290-1	8001-75-0	526	43440	yes	no			Details
charcoal, activated	264-846-4	64365-11-3	713	43480	yes	no		Only for use in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).	Details
chlorides of choline esters of coconut oil fatty acids	-	-	23	43515	yes	no	0.9 mg/kg		Details

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