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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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Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
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-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
butane	203-448-7	106-97-8	221	40570	yes	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
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
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
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
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
cis-1,2-cyclohexanedicarboxylic acid, salts	-	-	816	45704	yes	no	5 mg/kg		Details
cis-11-eicosenamide	-	10436-08-5	589	52645	yes	no			Details
cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts	-	-	817	38507	yes	no	5 mg/kg	Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %.	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
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	685	85950	yes	no	0.15 mg/kg	SML expressed as fluoride. Only to be used in layers of multi-layer materials not coming into direct contact with food.	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
cotton fibers	-	-	24	45280	yes	no			Details
cresols, butylated, styrenated	-	-	25	45440	yes	no	12 mg/kg		Details
cristobalite	238-455-4	14464-46-1	614	45560	yes	no			Details

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