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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 19 April 2024. Database contains 1080 unique substances/entries.

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Showing 301 - 400 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
sebacic acid	203-845-5	111-20-6	260	24280	no	no			Details
sebacic anhydride	219-882-5	2561-88-8	450	24430	no	no			Details
sodium sulphide	215-211-5	1313-82-2	401	24475	no	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
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
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Stearic acid	-	-	106	24550 89040	yes	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	yes	no			Details
styrene	202-851-5	100-42-5	193	24610	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Styrenesuphonic acid	-	-	656	24760	no	no	0.05 mg/kg		Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
succinic anhydride	203-570-0	108-30-5	233	24850	no	no			Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
5-sulphoisophthalic acid, monosodium salt, dimethyl ester	223-578-8	3965-55-7	471	24888	no	no	0.05 mg/kg		Details
5-sulphoisophthalic acid, salts	-	-	823	24889	no	no	5 mg/kg		Details
syrups, hydrolysed starch, hydrogenated	270-337-8	68425-17-2	724	24903	no	no		In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Terephthalic acid	-	-	785	24910	no	no			Details
terephthalic acid	202-830-0	100-21-0	785	24910	no	no			Details
terephthalic acid dichloride	202-829-5	100-20-9	191	24940	no	no			Details
terephthalic acid, dimethyl ester	204-411-8	120-61-6	288	24970	no	no			Details
1-tetradecene	214-306-9	1120-36-1	388	25080	no	no	0.05 mg/kg		Details
tetrafluoroethylene	204-126-9	116-14-3	281	25120	no	no	0.05 mg/kg		Details
tetrahydrofuran	203-726-8	109-99-9	246	25150	no	no	0.6 mg/kg		Details
2,2,4,4-tetramethylcyclobutane-1,3-diol	221-140-0	3010-96-6	881	25187	no	no	5 mg/kg	Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2,4,4-Tetramethylcyclobutane-1,3-diol	-	-	881	25187	no	no	5 mg/kg	Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.	Details
2,4-toluene diisocyanate	209-544-5	584-84-9	354	25210	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
2,6-toluene diisocyanate	202-039-0	91-08-7	167	25240	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
2,4-toluene diisocyanate dimer	247-953-0	26747-90-0	653	25270	no	no		1 mg/kg in final product expressed as isocyanate moiety.	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
trialkyl acetic acid (C7-C17), vinyl esters	-	-	6	25380	no	no	0.05 mg/kg		Details
triallylamine	203-048-2	102-70-5	205	25385	no	no		40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. Only to be used in hydrogels intended for non-direct food contact use.	Details
2,4,6-triamino-1,3,5-triazine	203-615-4	108-78-1	239	25420 19975 93720	yes	no	2.5 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Tricyclodecanedimethanol	-	-	655	25450	no	no	0.05 mg/kg		Details
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Triethyleneglycol	-	-	266	25510 94320	yes	no			Details
triethyleneglycol	203-953-2	112-27-6	266	25510 94320	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 Trimellitic acid	-	-	347	25540 13050	no	no			Details
trimellitic acid	208-432-3	528-44-9	347	25540 13050	no	no			Details
trimellitic anhydride	209-008-0	552-30-7	349	25550	no	no			Details
1,1,1-trimethylolpropane trimethacrylate	221-950-4	3290-92-4	463	25840	no	no	0.05 mg/kg		Details
2,3,6-trimethylphenol	219-330-3	2416-94-6	882	25872	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,3,6-Trimethylphenol	-	-	882	25872	no	no	0.05 mg/kg		Details
trimethyl trimellitate	219-547-3	2459-10-1	971	25885	no	no		Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.	Details
trioxane	203-812-5	110-88-3	255	25900	no	no	5 mg/kg		Details
tripropyleneglycol	246-466-0	24800-44-0	634	25910	no	no			Details
1,1,1-tris(4-hydroxyphenol)ethane THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE	405-800-7	27955-94-8	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,1,1-Tris(4-hydroxyphenol)ethane	-	-	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
urea	200-315-5	57-13-6	107	25960	no	no			Details
vinyl chloride	200-831-0	75-01-4	127	26050	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
vinylidene chloride	200-864-0	75-35-4	130	26110	no	no	0.01 mg/kg		Details
vinylidene fluoride	200-867-7	75-38-7	132	26140	no	no	5 mg/kg		Details
1-vinylimidazole	214-012-0	1072-63-5	387	26155	no	no	0.05 mg/kg		Details
N-vinyl-N-methylacetamide	221-698-5	3195-78-6	462	26170	no	no	0.02 mg/kg		Details
vinyltriethoxysilane	201-081-7	78-08-0	142	26305	no	no	0.05 mg/kg	Only to be used as a surface treatment agent.	Details
vinyltrimethoxysilane	220-449-8	2768-02-7	453	26320	no	no	0.05 mg/kg		Details
acetic acid	200-580-7	64-19-7	115	30000 10090	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 Acetic acid	-	-	115	30000 10090	yes	no			Details
acetic acid, butyl ester	204-658-1	123-86-4	300	30045	yes	no			Details
acetic acid, ethyl ester	205-500-4	141-78-6	327	30140	yes	no			Details
acetic anhydride	203-564-8	108-24-7	232	30280 10150	yes	no			Details
acetone	200-662-2	67-64-1	119	30295	yes	no			Details
acetylacetic acid, salts	-	-	7	30370	yes	no			Details
acetylated mono- and diglycerides of fatty acids	-	-	8	30401	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt	-	-	801	30607	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included)	-	-	9	30610	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters	-	-	10	30612	yes	no			Details
acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol	-	-	11	30960	yes	no			Details
acids, fatty, from animal or vegetable food fats and oils	-	-	12	31328	yes	no			Details
acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22)	-	-	878	31335	yes	no			Details
acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22)	-	-	879	31336	yes	no			Details
acids, fatty (C8-C22), esters with pentaerythritol	-	-	880	31348	yes	no			Details
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no	0.05 mg/kg	SML expressed as acrylic acid, 2-ethylhexyl ester.	Details
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no			Details
acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester	262-634-6	61167-58-6	700	31520	yes	yes	6 mg/kg		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
acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters	-	174254-23-0	777	31542	yes	no		0,5 % in final product.	Details
adipic acid	204-673-3	124-04-9	303	31730 12130	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 Adipic acid	-	-	303	31730 12130	yes	no			Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes	18 mg/kg		Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes			Details
alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated	604-520-4	146340-15-0	802	33105	yes	no	5 mg/kg		Details
alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)	-	-	13	33120	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
α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine	604-838-3	152261-33-1	803	33535	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Not to be used in contact with alcoholic foods.	Details
n-alkyl(C10-C13)benzenesulphonic acid	-	-	14	33801	yes	no	30 mg/kg		Details
alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines	-	-	15	34130	yes	yes	30 mg/kg		Details
alkyl(C8-C22)sulphonic acids	-	-	16	34230	yes	no	6 mg/kg		Details
alkyl(C10-C21)sulphonic acid, esters with phenol	293-728-5	91082-17-6	884	34240	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms	-	-	17	34281	yes	no			Details
aluminium calcium hydroxide phosphite, hydrate	-	191427-79-9	18	34475	yes	no			Details
aluminium fibers, flakes and powders	-	-	501	34480	yes	no			Details
aluminium hydroxide	244-492-7	21645-51-2	629	34560	yes	no			Details
aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate]	430-650-4	151841-65-5	771	34650	yes	no	5 mg/kg		Details
aluminium magnesium carbonate hydroxide	234-319-3	11097-59-9	592	34690	yes	no			Details
aluminium oxide	215-691-6	1344-28-1	418	34720	yes	no			Details
amines, bis(hydrogenated tallow alkyl) oxidised	418-370-0	143925-92-2	768	34850	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.	Details
2-aminobenzamide	201-851-2	88-68-6	164	34895	yes	no	0.05 mg/kg	Only for use in PET for water and beverages.	Details
3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether	236-946-8	13560-49-1	611	35120	yes	no			Details
6-amino-1,3-dimethyluracil	229-662-0	6642-31-5	495	35160	yes	no	5 mg/kg		Details
2-aminoethanol	205-483-3	141-43-5	326	35170 12763	yes	no	0.05 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

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