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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 601 - 700 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
iron oxide	215-570-8	1332-37-2	409	62240	yes	no			Details
1,2-propyleneglycol monooleate	215-549-3	1330-80-9	408	82960	yes	no			Details
sodium tetraborate	215-540-4	1330-43-4	407	87040	yes	no			Details
perfluoro[2-(n-propoxy)propanoic acid]	236-236-8	13252-13-6	861	71990	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.	Details
N,N'-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide	-	132459-54-2	764	13317	no	no	0.05 mg/kg	Purity > 98,1 % (w/w). Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).	Details
1,2-propyleneglycol monostearate	215-354-3	1323-39-3	406	83300	yes	no			Details
divinylbenzene	215-325-5	1321-74-0	405	16690	no	no	0.01 mg/kg	SML expressed as the sum of divinylbenzene and ethylvinylbenzene. It may contain up to 45 % (m/m) of ethylvinylbenzene	Details
molybdenum disulphide	215-263-9	1317-33-5	404	67200	yes	no			Details
zinc sulphide	215-251-3	1314-98-3	403	96320	yes	no			Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	402	96240	yes	no			Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	1050		yes	no		Only to be used in unplasticised polymers.	Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	1046		yes	no		Only to be used in unplasticised polymers. The restrictions and specifications specified for FCM substance No 788 shall be respected.	Details
sodium sulphide	215-211-5	1313-82-2	401	24475	no	no			Details
sodium hydroxide	215-185-5	1310-73-2	400	86720	yes	no			Details
potassium hydroxide	215-181-3	1310-58-3	399	81600	yes	no			Details
2-hydroxy-4-methoxybenzophenone	205-031-5	131-57-7	319	61360	yes	yes			Details
2,4-dihydroxybenzophenone	205-029-4	131-56-6	318	48640	yes	no			Details
2,2'-dihydroxy-4-methoxybenzophenone	205-026-8	131-53-3	317	48880	yes	yes			Details
phthalic acid, diallyl ester	205-016-3	131-17-9	316	23230	no	no	0.01 mg/kg		Details
antimony trioxide	215-175-0	1309-64-4	398	35760	yes	no			Details
magnesium oxide	215-171-9	1309-48-4	397	64720	yes	no			Details
magnesium hydroxide	215-170-3	1309-42-8	396	64640	yes	no			Details
calcium oxide	215-138-9	1305-78-8	395	41520	yes	no			Details
calcium hydroxide	215-137-3	1305-62-0	394	41280	yes	no			Details
bentonite A colloidal clay. Consists primarily of montmorillonite.	215-108-5	1302-78-9	393	37280	yes	no			Details
4,4'-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)	235-841-4	13003-12-8	608	40800	yes	yes	6 mg/kg		Details
3,3-bis(methoxymethyl)-2,5-dimethylhexane	430-800-9	129228-21-3	763	39925	yes	yes	0.05 mg/kg		Details
1,2-benziso-thiazol-3(2H)-one 1,1-dioxide, sodium salt	204-886-1	128-44-9	902		yes	no		The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (OJ L 83, 22.3.2012, p. 1).	Details
2,6-di-tert-butyl-p-cresol	204-881-4	128-37-0	315	46640	yes	no	3 mg/kg		Details
iron phosphide	235-798-1	12751-22-3	607	62245	yes	no		Only to be used in PET polymers and copolymers	Details
β-pinene	204-872-5	127-91-3	314	23500	no	no			Details
diphenyl sulphone	204-853-1	127-63-9	313	51570 16650	yes	no	3 mg/kg		Details
manganese hydroxide	882-488-2	12626-88-9	606	65200	yes	no			Details
methacrylonitrile	204-817-5	126-98-7	312	21490	no	no	0.01 mg/kg		Details
dipentaerythritol	204-794-1	126-58-9	311	51200 16480	yes	no			Details
2,2-dimethyl-1,3-propanediol	204-781-0	126-30-7	310	16390 22437	no	no	0.05 mg/kg		Details
sucrose octaacetate	204-772-1	126-14-7	309	91360	yes	no			Details
sucrose acetate isobutyrate	204-771-6	126-13-6	308	91200	yes	no			Details
acrylic acid, dicyclopentenyl ester	235-697-2	12542-30-2	605	11005	no	no	0.05 mg/kg		Details
poly(12-hydroxystearic acid)-polyethyleneimine copolymer	630-556-5	124578-12-7	812	80350	yes	no		Only to be used in plastics up to 0,1 % w/w. Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.	Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N'-diformylhexamethylenediamine LICHTSCHUTZMITTEL 1736	413-610-0	124172-53-8	795	40155	yes	no	0.05 mg/kg		Details
phosphoric acid, diphenyl 2-ethylhexyl ester	214-987-2	1241-94-7	392	72800	yes	yes	2.4 mg/kg		Details
carbon dioxide	204-696-9	124-38-9	307	42160	yes	no			Details
stearamide	204-693-2	124-26-5	306	88960	yes	no			Details
hexamethylenediamine	204-679-6	124-09-4	305	18460 15274	no	no	2.4 mg/kg		Details
caprylic acid	204-677-5	124-07-2	304	14320 41960	yes	no			Details
adipic acid	204-673-3	124-04-9	303	31730 12130	yes	no			Details
acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester SUMILIZER GS	413-850-6	123968-25-2	762	31530	yes	yes	5 mg/kg		Details
hydrotalcite	602-916-1	12304-65-3	604	60080	yes	no			Details
azelaic acid	204-669-1	123-99-9	302	12820	no	no			Details
stearic acid, butyl ester	204-666-5	123-95-5	301	89120	yes	no			Details
acetic acid, butyl ester	204-658-1	123-86-4	300	30045	yes	no			Details
levulinic acid	204-649-2	123-76-2	299	63840	yes	no			Details
butyraldehyde	204-646-6	123-72-8	298	14110	no	no			Details
propionic anhydride	204-638-2	123-62-6	297	23950	no	no			Details
propionaldehyde	204-623-0	123-38-6	296	23860	no	no			Details
1,4-dihydroxybenzene	204-617-8	123-31-9	295	48620 15940 18867	yes	no	0.6 mg/kg		Details
thiodipropionic acid, didodecyl ester	204-614-1	123-28-4	294	93120	yes	yes			Details
Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly [oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters	843-672-8	1227937-46-3	1076		yes	no	0.05 mg/kg	Only to be used (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.	Details
pyrophyllite	602-803-7	12269-78-2	603	83460	yes	no			Details
phosphorous acid, triethyl ester	204-552-5	122-52-1	293	23175	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
triisopropanolamine	204-528-4	122-20-3	292	94560	yes	no	5 mg/kg		Details
ozokerite	680-864-9	12198-93-5	602	70240	yes	no			Details
copper hydroxide phosphate	235-285-2	12158-74-6	972	45197	yes	no			Details
ammonium bromide	235-183-8	12124-97-9	601	35440	yes	no			Details
isophthalic acid	204-506-4	121-91-5	291	19150	no	no			Details
gallic acid, propyl ester	204-498-2	121-79-9	290	55360	yes	no			Details
hydromagnesite	811-989-0	12072-90-1	600	60030	yes	no			Details
thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate) SYNESAL M	404-440-8	120218-34-0	761	92930	yes	no	6 mg/kg		Details
barium tetraborate	-	12007-55-5	599	36840	yes	no			Details
hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)	234-448-5	12004-14-7	598	41600	yes	no			Details
mica	601-648-2	12001-26-2	597	67120	yes	no			Details
9,10-dihydroxy stearic acid	204-432-2	120-87-6	27	48960	yes	no	5 mg/kg		Details
1,2-dihydroxybenzene	204-427-5	120-80-9	289	24051 15880	no	no	6 mg/kg		Details
terephthalic acid, dimethyl ester	204-411-8	120-61-6	288	24970	no	no			Details
4-hydroxybenzoic acid, ethyl ester	204-399-4	120-47-8	287	60160	yes	no			Details
N,N-bis(2-hydroxyethyl)dodecanamide	204-393-1	120-40-1	923	39150	yes	no	5 mg/kg	The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, shall not result in a migration of diethanolamine higher than 0,3 mg/kg food.	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
perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt	682-238-0	1190931-27-1	1045		yes	no		Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.	Details
benzophenone	204-337-6	119-61-9	286	38240	yes	yes	0.6 mg/kg		Details
2,2'-methylene bis(4-methyl-6-tert-butylphenol)	204-327-1	119-47-1	285	66480	yes	yes			Details
salicylic acid, methyl ester	204-317-7	119-36-8	284	84880	yes	no	30 mg/kg		Details
perfluoromethyl perfluorovinyl ether	214-703-7	1187-93-5	391	22932	no	no	0.05 mg/kg	Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.	Details
2,2'-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite	403-020-1	118337-09-0	759	54300	yes	yes	6 mg/kg		Details
4-chlorophthalic anhydride	204-251-9	118-45-6	787	14628	no	no	0.05 mg/kg	SML expressed as 4-chlorophthalic acid.	Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no	0.6 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
3-chlorophthalic anhydride	204-179-8	117-21-5	786	14627	no	no	0.05 mg/kg	SML expressed as 3-chlorophthalic acid.	Details
gallic acid, dodecyl ester	214-620-6	1166-52-5	390	55200	yes	no			Details
hexafluoropropylene	204-127-4	116-15-4	282	18430	no	no	0.01 mg/kg		Details
tetrafluoroethylene	204-126-9	116-14-3	281	25120	no	no	0.05 mg/kg		Details
phosphoric acid, trichloroethyl ester	204-118-5	115-96-8	280	73720	yes	no	0.01 mg/kg		Details
pentaerythritol	204-104-9	115-77-5	279	22840 71600	yes	no			Details
hexachloroendomethylenetetrahydrophthalic acid	204-078-9	115-28-6	278	18250	no	no	0.01 mg/kg		Details
hexachloroendomethylenetetrahydrophthalic anhydride	204-077-3	115-27-5	277	18280	no	no	0.01 mg/kg		Details
isobutene	204-066-3	115-11-7	276	19000	no	no			Details
propylene	204-062-1	115-07-1	275	23980	no	no			Details
2,6-naphthalenedicarboxylic acid	214-527-0	1141-38-4	389	22360	no	no	5 mg/kg		Details
1-tetradecene	214-306-9	1120-36-1	388	25080	no	no	0.05 mg/kg		Details

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