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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 03 May 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)
polyethyleneglycol sorbitan monolaurate 1 - 6.5 moles ethoxylated	500-018-3	9005-64-5	568	79040	yes	no			Details
1,2-propyleneglycol alginate	618-414-0	9005-37-2	567	82080	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 Alginic acid	-	-	566	33350	yes	no			Details
alginic acid	232-680-1	9005-32-7	566	33350	yes	no			Details
hydroxyethyl starch	618-410-9	9005-27-0	565	61120	yes	no			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
polyethyleneglycol monoricinoleate	618-404-6	9004-97-1	563	78320	yes	yes	42 mg/kg		Details
nitrocellulose	618-392-2	9004-70-0	562	22450	no	no			Details
methylcellulose	618-391-7	9004-67-5	561	66240	yes	no			Details
methylhydroxypropylcellulose	618-389-6	9004-65-3	560	66700	yes	no			Details
glycerol monopalmitate, ester with ascorbic acid	-	-	56	57200	yes	no			Details
hydroxypropylcellulose	618-388-0	9004-64-2	559	61680	yes	no			Details
hydroxyethylcellulose	618-387-5	9004-62-0	558	60560	yes	no			Details
methylethylcellulose	-	9004-59-5	557	66640	yes	no			Details
ethylhydroxyethylcellulose	618-385-4	9004-58-4	556	54260	yes	no			Details
ethylcellulose	618-384-9	9004-57-3	555	53280	yes	no			Details
cellulose acetate butyrate	618-381-2	9004-36-8	554	43300	yes	no			Details
cellulose	232-674-9	9004-34-6	553	43280 14500	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
poloxamer 407	923-642-1	106392-12-5	551	79920	yes	no			Details
Oxirane, 2-methyl-, polymer with oxirane	618-355-0	9003-11-6	551	79920	yes	no			Details
polypropylene wax	618-352-4	9003-07-0	550	81060	yes	no			Details
glycerol monooleate, ester with citric acid	-	-	55	57120	yes	no			Details
polyethylene wax	618-339-3	9002-88-4	549	80000	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
gelatin A complex combination of proteins obtained by hydrolysis of collagen by boiling skin, tendons, ligaments, bones, etc.	232-554-6	9000-70-8	547	55440	yes	no			Details
pectin	232-553-0	9000-69-5	546	71440	yes	no			Details
tragacanth gum	232-552-5	9000-65-1	545	93680	yes	no			Details
guar gum	232-536-8	9000-30-0	544	58400	yes	no			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
carboxymethylcellulose	618-326-2	9000-11-7	542	42640	yes	no			Details
gum arabic	232-519-5	9000-01-5	541	58480	yes	no			Details
lignosulphonic acid	617-129-9	8062-15-5	540	63940	yes	no	0.24 mg/kg	Only to be used as dispersant for plastics dispersions.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Lignosulphonic acid	-	-	540	63940	yes	no	0.24 mg/kg	Only to be used as dispersant for plastics dispersions.	Details
glycerol monooleate, ester with ascorbic acid	-	-	54	57040	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, ester with methanol	232-476-2	8050-15-5	536	84320	yes	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
polyphosphoric acids	232-417-0	8017-16-1	534	80720	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 Polyphosphoric acids	-	-	534	80720	yes	no			Details
carnauba wax The wax derived from Copernicia cerifera, Palmae.	232-399-4	8015-86-9	533	42720	yes	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
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
candelilla wax The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.	232-347-0	8006-44-8	530	41760	yes	no			Details
glycerol, esters with stearic acid	234-325-6	11099-07-3	53	56585	yes	no			Details
montan wax Wax obtained by extraction of lignite.	232-313-5	8002-53-7	529	67850	yes	no			Details
lecithin The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.	232-307-2	8002-43-5	528	63760	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
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
japan wax	-	8001-39-6	525	62640	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
copper bromide	232-131-6	7787-70-4	523	45195	yes	no			Details
chlorine	231-959-5	7782-50-5	522	14530	no	no			Details
graphite	231-955-3	7782-42-5	521	58320	yes	no			Details
manganese chloride	231-869-6	7773-01-5	520	65120	yes	no			Details
glycerol, esters with ricinoleic acid	261-327-4	58561-47-0	52	56580	yes	no			Details
sodium thiosulphate	231-867-5	7772-98-7	519	87120	yes	no			Details
arachidonic acid	-	7771-44-0	518	35845	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 Arachidonic acid	-	-	518	35845	yes	no			Details
potassium bromide	231-830-3	7758-02-3	517	81520	yes	no			Details
sodium sulphite	231-821-4	7757-83-7	516	86960	yes	no			Details
water	231-791-2	7732-18-5	515	95855 26360	yes	no		In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].	Details
sulphur	231-722-6	7704-34-9	514	91840	yes	no			Details
sodium iodide	231-679-3	7681-82-5	513	86800	yes	no			Details
potassium iodide	231-659-4	7681-11-0	512	81680	yes	no			Details
sulphuric acid	231-639-5	7664-93-9	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 Sulphuric acid	-	-	511	91920	yes	no			Details
ammonia	231-635-3	7664-41-7	510	12789 35320	yes	no			Details
glycerol, esters with propionic acid	-	-	51	56570	yes	no			Details
phosphoric acid	231-633-2	7664-38-2	509	23170 72640	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 Phosphoric acid	-	-	509	23170 72640	yes	no			Details
sodium bromide	231-599-9	7647-15-6	508	86560	yes	no			Details
hydrochloric acid	231-595-7	7647-01-0	507	59990	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 Hydrochloric acid	-	-	507	59990	yes	no			Details
sodium nitrite	231-555-9	7632-00-0	506	86920	yes	no	0.6 mg/kg		Details
sodium bisulphite	231-548-0	7631-90-5	505	86480	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
β-dextrin	231-493-2	7585-39-9	503	46080	yes	no			Details
4,4'-oxybis(benzenesulphonyl azide)	431-850-4	7456-68-0	502	22778	no	no	0.05 mg/kg		Details
aluminium fibers, flakes and powders	-	-	501	34480	yes	no			Details
2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene	230-426-4	7128-64-5	500	38560	yes	yes	0.6 mg/kg		Details
glycerol, esters with palmitic acid	234-400-3	11140-06-0	50	56550	yes	no			Details
trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester	-	-	5	25360	no	no	0.01 mg/kg	1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	Details
malic acid	230-022-8	6915-15-7	499	19965 65020	yes	no		In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Malic acid	-	-	499	19965 65020	yes	no		In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.	Details
3,3'-dimethyl-4,4'-diaminodicyclohexylmethane	229-962-1	6864-37-5	498	16210	no	no	0.05 mg/kg	Only to be used in polyamides.	Details
2,2,4-trimethyl-1,3-pentanediol diisobutyrate	229-934-9	6846-50-0	497	95020	yes	no	5 mg/kg	Only to be used in single-use gloves.	Details
pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	229-722-6	6683-19-8	496	71680	yes	no			Details
6-amino-1,3-dimethyluracil	229-662-0	6642-31-5	495	35160	yes	no	5 mg/kg		Details
hypophosphorous acid	228-601-5	6303-21-5	494	62140	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 Hypophosphorous acid	-	-	494	62140	yes	no			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
2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester	228-250-8	6197-30-4	492	45650	yes	no	0.05 mg/kg		Details
1,2-propyleneglycol distearate	228-229-3	6182-11-2	491	82720	yes	no			Details
diphenylmethane-2,4'-diisocyanate	227-534-9	5873-54-1	490	16600	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
glycerol, esters with oleic acid	253-407-2	37220-82-9	49	56540	yes	no			Details

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