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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 01 maj 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)
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
guar gum	232-536-8	9000-30-0	544	58400	yes	no			Details
tragacanth gum	232-552-5	9000-65-1	545	93680	yes	no			Details
pectin	232-553-0	9000-69-5	546	71440	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
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
polyethylene wax	618-339-3	9002-88-4	549	80000	yes	no			Details
glycerol monooleate, ester with citric acid	-	-	55	57120	yes	no			Details
polypropylene wax	618-352-4	9003-07-0	550	81060	yes	no			Details
Oxirane, 2-methyl-, polymer with oxirane	618-355-0	9003-11-6	551	79920	yes	no			Details
poloxamer 407	923-642-1	106392-12-5	551	79920	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
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
ethylcellulose	618-384-9	9004-57-3	555	53280	yes	no			Details
ethylhydroxyethylcellulose	618-385-4	9004-58-4	556	54260	yes	no			Details
methylethylcellulose	-	9004-59-5	557	66640	yes	no			Details
hydroxyethylcellulose	618-387-5	9004-62-0	558	60560	yes	no			Details
hydroxypropylcellulose	618-388-0	9004-64-2	559	61680	yes	no			Details
glycerol monopalmitate, ester with ascorbic acid	-	-	56	57200	yes	no			Details
methylhydroxypropylcellulose	618-389-6	9004-65-3	560	66700	yes	no			Details
methylcellulose	618-391-7	9004-67-5	561	66240	yes	no			Details
nitrocellulose	618-392-2	9004-70-0	562	22450	no	no			Details
polyethyleneglycol monoricinoleate	618-404-6	9004-97-1	563	78320	yes	yes	42 mg/kg		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
hydroxyethyl starch	618-410-9	9005-27-0	565	61120	yes	no			Details
alginic acid	232-680-1	9005-32-7	566	33350	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
1,2-propyleneglycol alginate	618-414-0	9005-37-2	567	82080	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
glycerol monopalmitate, ester with citric acid	-	-	57	57280	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
rubber, natural	232-689-0	9006-04-6	574	84560 24250	yes	no			Details
polydimethylsiloxane (Mw > 6800 Da)	613-156-5	63148-62-9	575	76721	yes	no		Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).	Details
hydroxyethylmethylcellulose	618-528-0	9032-42-2	576	60880	yes	no			Details
isobutylene-butene copolymer	695-178-5	9044-17-1	577	62280	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
hydroxypropyl starch	618-565-2	9049-76-7	579	61800	yes	no			Details
glycerol monostearate, ester with ascorbic acid	-	-	58	57600	yes	no			Details
α-dextrin	233-007-4	10016-20-3	580	46070	yes	no			Details
barium nitrate	233-020-5	10022-31-8	581	36800	yes	no			Details
di-n-octyltin bis(2-ethylhexyl maleate)	233-117-2	10039-33-5	582	50240	yes	no			Details
boron nitride	233-136-6	10043-11-5	583	40400	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 Boric acid	-	-	584	40320 13620	yes	no			Details
boric acid	233-139-2	10043-35-3	584	40320 13620	yes	no			Details
calcium chloride	233-140-8	10043-52-4	585	41120	yes	no			Details

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