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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 501 - 600 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
adipic anhydride	218-001-1	2035-75-8	432	12280	no	no			Details
alginic acid	232-680-1	9005-32-7	566	33350	yes	no			Details
alkyl(C10-C21)sulphonic acid, esters with phenol	293-728-5	91082-17-6	884	34240	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.	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 hydroxide	244-492-7	21645-51-2	629	34560	yes	no			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
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
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
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
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(2,6-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(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 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
carbonyl chloride	200-870-3	75-44-5	133	23155 14380	no	no	0.01 mg/kg	1 mg/kg in final product.	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
cellulose	232-674-9	9004-34-6	553	43280 14500	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
chlorine	231-959-5	7782-50-5	522	14530	no	no			Details
chlorodifluoromethane	200-871-9	75-45-6	134	43680	yes	no	6 mg/kg	Content of chlorofluoromethane less than 1 mg/kg of the substance.	Details
chlorotrifluoroethylene	201-201-8	79-38-9	148	14650	no	no	0.01 mg/kg		Details
citric acid	201-069-1	77-92-9	139	44160 14680	yes	no			Details
citric acid, triethyl ester	201-070-7	77-93-0	140	44640	yes	no			Details
cobalt oxide	234-334-5	11104-61-3	593	44960	yes	no			Details
copper bromide	232-131-6	7787-70-4	523	45195	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
crotonic acid	223-077-4	3724-65-0	467	45600 14800	yes	no			Details
cyclohexyl isocyanate	221-639-3	3173-53-3	460	14950	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
cyclohexylamine	203-629-0	108-91-8	240	45760	yes	no			Details
cyclooctene	213-245-5	931-88-4	381	15030	no	no	0.05 mg/kg	Only to be used in polymers contacting foods for which simulant A is laid down.	Details
dammar Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Shorea, Dipterocarpaceae).	232-528-4	9000-16-2	543	45920	yes	no			Details
di-n-dodecyltin bis(isooctyl mercaptoacetate)	281-837-0	84030-61-5	747	47600	yes	yes			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 bis(ethyl maleate)	268-500-3	68109-88-6	29	50360	yes	no			Details
di-n-octyltin bis(isooctyl maleate)	251-576-7	33568-99-9	676	50400	yes	no			Details
di-n-octyltin bis(isooctyl mercaptoacetate)	247-666-0	26401-97-8	646	50480	yes	no			Details
di-n-octyltin dilaurate	222-883-3	3648-18-8	466	50640	yes	no			Details
di-n-octyltin dimaleate	239-625-0	15571-60-5	620	50720	yes	no			Details
di-n-octyltin ethyleneglycol bis(mercaptoacetate)	260-414-4	56875-68-4	736	50960	yes	no			Details
di-n-octyltin mercaptoacetate	239-581-2	15535-79-2	618	51040	yes	no			Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
diatomaceous earth, soda ash flux-calcined	272-489-0	68855-54-9	734	46380	yes	no			Details
dibenzylidene sorbitol	251-136-4	32647-67-9	674	46480	yes	no			Details
dicyanodiamide	207-312-8	461-58-5	340	47440	yes	no	60 mg/kg		Details
dicyclohexylmethane-4,4'-diisocyanate	225-863-2	5124-30-1	485	15700 13560	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details

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