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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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Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
soybean oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).	232-274-4	8001-22-7	524	24520	no	no			Details
sorbitol monostearate	248-027-9	26836-47-5	654	88600	yes	no			Details
sorbitol	200-061-5	50-70-4	100	88320 24490	yes	no			Details
sorbitan tristearate	247-891-4	26658-19-5	651	88240	yes	no			Details
sorbitan tripalmitate	258-994-9	54140-20-4	693	88160	yes	no			Details
sorbitan trioleate	247-569-3	26266-58-0	644	88080	yes	no			Details
sorbitan tetrastearate	262-958-8	61752-68-9	702	87920	yes	no			Details
sorbitan monostearate	215-664-9	1338-41-6	415	87840	yes	no			Details
sorbitan monopalmitate	247-568-8	26266-57-9	643	87760	yes	no			Details
sorbitan monooleate	215-665-4	1338-43-8	416	87680	yes	no			Details
sorbitan monolaurate	215-663-3	1338-39-2	414	87600	yes	no			Details
sorbitan monobehenate	263-600-3	62568-11-0	709	87520	yes	no			Details
sorbitan dioleate	249-448-0	29116-98-1	666	87280	yes	no			Details
sorbic acid	203-768-7	110-44-1	252	87200	yes	no			Details
sodium thiosulphate	231-867-5	7772-98-7	519	87120	yes	no			Details
sodium tetraborate	215-540-4	1330-43-4	407	87040	yes	no			Details
sodium sulphite	231-821-4	7757-83-7	516	86960	yes	no			Details
sodium sulphide	215-211-5	1313-82-2	401	24475	no	no			Details
sodium nitrite	231-555-9	7632-00-0	506	86920	yes	no	0.6 mg/kg		Details
sodium monoalkyl dialkylphenoxybenzenedisulphonate	-	-	88	86880	yes	no	9 mg/kg		Details
sodium iodide	231-679-3	7681-82-5	513	86800	yes	no			Details
sodium hydroxide	215-185-5	1310-73-2	400	86720	yes	no			Details
sodium bromide	231-599-9	7647-15-6	508	86560	yes	no			Details
sodium bisulphite	231-548-0	7631-90-5	505	86480	yes	no			Details
silicon dioxide, silanated	-	-	87	86285	yes	no		For synthetic amorphous silicon dioxide, silanated: primary particles of 1-100 nm which are aggregated to a size of 0,1-1 µm and may form agglomerates within the size distribution of 0,3 µm to the mm size.	Details
silicon dioxide	231-545-4	7631-86-9	504	86240	yes	no		For synthetic amorphous silicon dioxide: primary particles of 1 - 100 nm which are aggregated to a size of 0,1 - 1 µm which may form agglomerates within the size distribution of 0,3 µm to the mm size.	Details
silicon carbide	206-991-8	409-21-2	339	86160	yes	no			Details
silicic acid, silylated	-	-	86	86000	yes	no			Details
silicic acid	215-683-2	1343-98-2	417	85680	yes	no			Details
silicates, natural, silanated (with the exception of asbestos)	-	-	85	85610	yes	no			Details
silicates, natural (with the exception of asbestos)	-	-	84	85601	yes	no			Details
sebacic anhydride	219-882-5	2561-88-8	450	24430	no	no			Details
sebacic acid, dibutyl ester	203-672-5	109-43-3	242	85360	yes	no			Details
sebacic acid	203-845-5	111-20-6	260	24280	no	no			Details
salicylic acid, methyl ester	204-317-7	119-36-8	284	84880	yes	no	30 mg/kg		Details
salicylic acid, 4-tert-butylphenyl ester	201-728-3	87-18-3	160	84800	yes	yes	12 mg/kg		Details
rubber, natural	232-689-0	9006-04-6	574	84560 24250	yes	no			Details
rosin, hydrogenated, ester with pentaerythritol	264-848-5	64365-17-9	714	84400	yes	no			Details
rosin, hydrogenated, ester with methanol	232-476-2	8050-15-5	536	84320	yes	no			Details
rosin, hydrogenated, ester with glycerol	266-042-9	65997-13-9	718	84240	yes	no			Details
rosin, hydrogenated	266-041-3	65997-06-0	717	84210	yes	no			Details
rosin, ester with pentaerythritol	232-479-9	8050-26-8	537	84080	yes	no			Details
rosin, ester with glycerol	232-482-5	8050-31-5	538	84000	yes	no			Details
rosin tall oil A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.	232-484-6	8052-10-6	539	24160	no	no			Details
rosin A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.	232-475-7	8050-09-7	535	24100 24190 83840 24130	yes	no			Details
ricinoleic acid	205-470-2	141-22-0	324	83700	yes	yes	42 mg/kg		Details
resorcinol diglycidyl ether	202-987-5	101-90-6	199	24073	no	no	0.01 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
resin acids and rosin acids	277-299-1	73138-82-6	741	83610 24070	yes	no			Details
reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin	270-476-4	68442-12-6	726	83599	yes	yes			Details
reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous trichloride and biphenyl	432-130-2	119345-01-6	760	83595	yes	no	18 mg/kg	Composition: 4,4'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w ()),4,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w ()),3,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w ()),4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w ()),tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w ()),4,4'-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w ())(*)Quantity of substance used/quantity of formulationOther specifications: Phosphor content of min. 5,4 % to max. 5,9 %,Acid value of max. 10 mg KOH per gram,Melt range of 85- 110 °C.	Details

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