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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 801 - 900 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids	-	-	72	76815	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).	Details
polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate	-	-	76	77732	yes	no	0.05 mg/kg	Only for use in PET.	Details
polyethylene wax	618-339-3	9002-88-4	549	80000	yes	no			Details
polyethylene waxes, oxidised	614-498-8	68441-17-8	811	80077	yes	no	60 mg/kg		Details
polyethyleneglycol 1 - 4.5 moles ethoxylated	500-038-2	25322-68-3	638	23590 76960	yes	no			Details
polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate	-	-	77	77733	yes	no	0.05 mg/kg	Only for use in PET.	Details
polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols	-	-	799	77708	yes	no	1.8 mg/kg	In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.	Details
polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, salts	-	-	78	77897	yes	no	5 mg/kg		Details
polyethyleneglycol ester of castor oil 1 - 6.5 moles ethoxylated	500-151-7	61791-12-6	708	77520	yes	no	42 mg/kg		Details
polyethyleneglycol ester of hydrogenated castor oil 1 - 6.5 moles ethoxylated	500-147-5	61788-85-0	704	77600	yes	no			Details
polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulphates	-	-	75	77702	yes	no			Details
polyethyleneglycol sorbitan monolaurate 1 - 6.5 moles ethoxylated	500-018-3	9005-64-5	568	79040	yes	no			Details
polyethyleneglycol sorbitan monooleate 1 - 6.5 moles ethoxylated	500-019-9	9005-65-6	569	79120	yes	no			Details
polyethyleneglycol sorbitan monopalmitate	618-421-9	9005-66-7	570	79200	yes	no			Details
polyethyleneglycol sorbitan monostearate 1 - 6.5 moles ethoxylated	500-020-4	9005-67-8	571	79280	yes	no			Details
polyethyleneglycol sorbitan trioleate	618-422-4	9005-70-3	572	79360	yes	no			Details
polyethyleneglycol sorbitan tristearate	618-424-5	9005-71-4	573	79440	yes	no			Details
polyethyleneglycol tridecyl ether phosphate	618-558-4	9046-01-9	578	79600	yes	no	5 mg/kg	For materials and articles intended for contact with aqueous foods only. Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.	Details
polyethyleneglycol-30 dipolyhydroxystearate	680-598-3	70142-34-6	737	77370	yes	no			Details
polyglycerol	607-759-2	25618-55-7	1017		yes	no		To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.	Details
polyglycerol ricinoleate	608-428-5	29894-35-7	668	80240	yes	no			Details
polyoxyalkyl (C2-C4) dimethylpolysiloxane	-	-	79	80640	yes	no			Details
polyphosphoric acids	232-417-0	8017-16-1	534	80720	yes	no			Details
polypropylene wax	618-352-4	9003-07-0	550	81060	yes	no			Details
polypropyleneglycol 1 - 4.5 moles propoxylated	500-039-8	25322-69-4	639	23651 80800	yes	no			Details
polyvinylpyrrolidone	618-363-4	9003-39-8	552	81500	yes	no		The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC [OJ L 253, 20.9.2008, p. 1.].	Details
potassium bromide	231-830-3	7758-02-3	517	81520	yes	no			Details
potassium hydroxide	215-181-3	1310-58-3	399	81600	yes	no			Details
potassium iodide	231-659-4	7681-11-0	512	81680	yes	no			Details
powders, flakes and fibres of brass, bronze, copper, stainless steel, tin, iron and alloys of copper, tin and iron	-	-	80	81760	yes	no			Details
propionaldehyde	204-623-0	123-38-6	296	23860	no	no			Details
propionic acid	201-176-3	79-09-4	146	82000 23890	yes	no			Details
propionic acid, vinyl ester	203-293-5	105-38-4	211	23920	no	no			Details
propionic anhydride	204-638-2	123-62-6	297	23950	no	no			Details
propylene	204-062-1	115-07-1	275	23980	no	no			Details
propylene oxide	200-879-2	75-56-9	135	24010	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
propylhydroxyethylcellulose	-	-	81	83320	yes	no			Details
propylhydroxymethylcellulose	-	-	82	83325	yes	no			Details
propylhydroxypropylcellulose	-	-	83	83330	yes	no			Details
pyromellitic anhydride	201-898-9	89-32-7	166	24057	no	no	0.05 mg/kg		Details
pyrophosphoric acid	219-574-0	2466-09-3	445	83440	yes	no			Details
pyrophosphorous acid	-	13445-56-2	609	83455	yes	no			Details
pyrophyllite	602-803-7	12269-78-2	603	83460	yes	no			Details
quartz	238-878-4	14808-60-7	616	83470	yes	no			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
resin acids and rosin acids	277-299-1	73138-82-6	741	83610 24070	yes	no			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
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
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, ester with glycerol	232-482-5	8050-31-5	538	84000	yes	no			Details
rosin, ester with pentaerythritol	232-479-9	8050-26-8	537	84080	yes	no			Details
rosin, hydrogenated	266-041-3	65997-06-0	717	84210	yes	no			Details
rosin, hydrogenated, ester with glycerol	266-042-9	65997-13-9	718	84240	yes	no			Details
rosin, hydrogenated, ester with methanol	232-476-2	8050-15-5	536	84320	yes	no			Details
rosin, hydrogenated, ester with pentaerythritol	264-848-5	64365-17-9	714	84400	yes	no			Details
rubber, natural	232-689-0	9006-04-6	574	84560 24250	yes	no			Details
salicylic acid, methyl ester	204-317-7	119-36-8	284	84880	yes	no	30 mg/kg		Details
sebacic acid	203-845-5	111-20-6	260	24280	no	no			Details
sebacic acid, dibutyl ester	203-672-5	109-43-3	242	85360	yes	no			Details
sebacic anhydride	219-882-5	2561-88-8	450	24430	no	no			Details
silicates, natural (with the exception of asbestos)	-	-	84	85601	yes	no			Details
silicates, natural, silanated (with the exception of asbestos)	-	-	85	85610	yes	no			Details
silicic acid	215-683-2	1343-98-2	417	85680	yes	no			Details
silicic acid, silylated	-	-	86	86000	yes	no			Details
silicon carbide	206-991-8	409-21-2	339	86160	yes	no			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 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
sodium bisulphite	231-548-0	7631-90-5	505	86480	yes	no			Details
sodium bromide	231-599-9	7647-15-6	508	86560	yes	no			Details
sodium hydroxide	215-185-5	1310-73-2	400	86720	yes	no			Details
sodium iodide	231-679-3	7681-82-5	513	86800	yes	no			Details
sodium monoalkyl dialkylphenoxybenzenedisulphonate	-	-	88	86880	yes	no	9 mg/kg		Details
sodium nitrite	231-555-9	7632-00-0	506	86920	yes	no	0.6 mg/kg		Details
sodium sulphide	215-211-5	1313-82-2	401	24475	no	no			Details
sodium sulphite	231-821-4	7757-83-7	516	86960	yes	no			Details
sodium tetraborate	215-540-4	1330-43-4	407	87040	yes	no			Details
sodium thiosulphate	231-867-5	7772-98-7	519	87120	yes	no			Details
sorbic acid	203-768-7	110-44-1	252	87200	yes	no			Details
sorbitan dioleate	249-448-0	29116-98-1	666	87280	yes	no			Details
sorbitan monobehenate	263-600-3	62568-11-0	709	87520	yes	no			Details
sorbitan monolaurate	215-663-3	1338-39-2	414	87600	yes	no			Details
sorbitan monooleate	215-665-4	1338-43-8	416	87680	yes	no			Details
sorbitan monopalmitate	247-568-8	26266-57-9	643	87760	yes	no			Details
sorbitan monostearate	215-664-9	1338-41-6	415	87840	yes	no			Details
sorbitan tetrastearate	262-958-8	61752-68-9	702	87920	yes	no			Details
sorbitan trioleate	247-569-3	26266-58-0	644	88080	yes	no			Details
sorbitan tripalmitate	258-994-9	54140-20-4	693	88160	yes	no			Details
sorbitan tristearate	247-891-4	26658-19-5	651	88240	yes	no			Details
sorbitol	200-061-5	50-70-4	100	88320 24490	yes	no			Details
sorbitol monostearate	248-027-9	26836-47-5	654	88600	yes	no			Details
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
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	60 mg/kg		Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no			Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	30 mg/kg	In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.	Details
starch, edible High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.	232-679-6	9005-25-8	564	24540 88800	yes	no			Details
starch, hydrolysed	686-629-7	68412-29-3	723	88880	yes	no			Details
stearamide	204-693-2	124-26-5	306	88960	yes	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	yes	no			Details
stearic acid, butyl ester	204-666-5	123-95-5	301	89120	yes	no			Details
stearic acid, esters with ethyleneglycol	-	-	89	89440	yes	no			Details

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