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

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Showing 701 - 800 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
phthalic acid	201-873-2	88-99-3	192	23187	no	no			Details
phthalic acid	201-873-2	88-99-3	165	23200 74480	yes	no			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
2,2'-methylene bis(4-ethyl-6-tert-butylphenol)	201-814-0	88-24-4	163	66400	yes	yes			Details
mannitol	201-770-2	87-78-5	162	65520	yes	no			Details
L-(+)-tartaric acid	201-766-0	87-69-4	161	92160	yes	no			Details
salicylic acid, 4-tert-butylphenyl ester	201-728-3	87-18-3	160	84800	yes	yes	12 mg/kg		Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no	6 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic anhydride	201-607-5	85-44-9	158	23380 76320	yes	no			Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no	0.12 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
methacrylic acid, methyl ester	201-297-1	80-62-6	156	21130	no	no			Details
α-pinene	201-291-9	80-56-8	155	23470	no	no			Details
4,4'-dihydroxydiphenyl sulphone	201-250-5	80-09-1	154	13617 16090	no	no	0.05 mg/kg		Details
4,4'-diaminodiphenyl sulphone	201-248-4	80-08-0	153	15267	no	no	5 mg/kg		Details
4,4'-dichlorodiphenyl sulphone	201-247-9	80-07-9	152	15610	no	no	0.05 mg/kg		Details
2,2-bis(4-hydroxyphenyl)propane	201-245-8	80-05-7	151	13480 13607	no	no	0.05 mg/kg	Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union]. Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].	Details
methacrylic acid	201-204-4	79-41-4	150	20020	no	no			Details
methacrylamide	201-202-3	79-39-0	149	19990	no	no	0.01 mg/kg		Details
chlorotrifluoroethylene	201-201-8	79-38-9	148	14650	no	no	0.01 mg/kg		Details
glycolic acid	201-180-5	79-14-1	794	18117	no	no		Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.	Details
acrylic acid	201-177-9	79-10-7	147	10690	no	no			Details
propionic acid	201-176-3	79-09-4	146	82000 23890	yes	no			Details
acrylamide	201-173-7	79-06-1	145	10630	no	no	0.01 mg/kg		Details
2-methyl-1,3-butadiene	201-143-3	78-79-5	144	21640 19243	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
isopentane	201-142-8	78-78-4	143	62450	yes	no			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
1,1,1-trimethylolpropane	201-074-9	77-99-6	141	94960 25600 13380	yes	no	6 mg/kg		Details
citric acid, triethyl ester	201-070-7	77-93-0	140	44640	yes	no			Details
citric acid	201-069-1	77-92-9	139	44160 14680	yes	no			Details
tri-n-butyl acetyl citrate	201-067-0	77-90-7	138	93760	yes	no			Details
2,2'-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	201-044-5	77-62-3	137	66580	yes	yes			Details
camphor	200-945-0	76-22-2	136	41680	yes	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
chlorodifluoromethane	200-871-9	75-45-6	134	43680	yes	no	6 mg/kg	Content of chlorofluoromethane less than 1 mg/kg of the substance.	Details
carbonyl chloride	200-870-3	75-44-5	133	23155 14380	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
vinylidene fluoride	200-867-7	75-38-7	132	26140	no	no	5 mg/kg		Details
1,1-difluoroethane	200-866-1	75-37-6	131	48460	yes	no			Details
vinylidene chloride	200-864-0	75-35-4	130	26110	no	no	0.01 mg/kg		Details
isobutane	200-857-2	75-28-5	1069		yes	no		Only to be used as a blowing agent.	Details
ethylene oxide	200-849-9	75-21-8	129	17020	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
acetaldehyde	200-836-8	75-07-0	128	10060	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
acetylene	200-816-9	74-86-2	126	10210	no	no			Details
ethylene	200-815-3	74-85-1	125	16950	no	no			Details
1-pentanol	200-752-1	71-41-0	124	22870	no	no			Details
1-butanol	200-751-6	71-36-3	123	13840	no	no			Details
1-propanol	200-746-9	71-23-8	122	23800	no	no			Details
dimethyl sulphoxide	200-664-3	67-68-5	120	49540	yes	no			Details
acetone	200-662-2	67-64-1	119	30295	yes	no			Details
2-propanol	200-661-7	67-63-0	118	81882 23830	yes	no			Details
methanol	200-659-6	67-56-1	117	21550	no	no			Details
benzoic acid	200-618-2	65-85-0	116	37600 13090	yes	no			Details
acetic acid	200-580-7	64-19-7	115	30000 10090	yes	no			Details
formic acid	200-579-1	64-18-6	114	55040	yes	no			Details
ethanol	200-578-6	64-17-5	113	52800 16780	yes	no			Details
linoleic acid	200-470-9	60-33-3	112	64015	yes	no			Details
ethylenediaminetetraacetic acid	200-449-4	60-00-4	111	53600	yes	no			Details
alpha-tocopherol	200-412-2	59-02-9	110	93520	yes	no			Details
alpha-tocopherol acetate	200-405-4	58-95-7	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
1,2-propanediol	200-338-0	57-55-6	109	23740 81840	yes	no			Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
urea	200-315-5	57-13-6	107	25960	no	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	yes	no			Details
palmitic acid	200-312-9	57-10-3	105	22780 70400	yes	no			Details
hexadecyltrimethylammonium bromide	200-311-3	57-09-0	104	58960	yes	no	6 mg/kg		Details
glycerol	200-289-5	56-81-5	103	18100 55920	yes	no			Details
2,4-diamino-6-hydroxypyrimidine	200-254-4	56-06-4	864	46330	yes	no	5 mg/kg	Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.	Details
glucose	200-075-1	50-99-7	102	17530	no	no			Details
ascorbic acid	200-066-2	50-81-7	101	36000	yes	no			Details
sorbitol	200-061-5	50-70-4	100	88320 24490	yes	no			Details
lactic acid	200-018-0	50-21-5	99	19460 62960	yes	no			Details
formaldehyde	200-001-8	50-00-0	98	17260 54880	yes	no			Details
white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks	-	-	95	95883	yes	no		Average molecular weight not less than 480 Da. Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)	Details
waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity	-	-	94	95859	yes	no		Average molecular weight not less than 500 Da. Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)	Details
waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity	-	-	93	95858	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. Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).	Details
trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids	-	-	924	94987	yes	no	0.05 mg/kg	Only for use in PET in contact with all types of foods other than fatty, high- alcoholic and dairy products.	Details
trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid	-	-	815	94985	yes	no	5 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid	-	-	815	94985	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
tricyclodecanedimethanol bis(hexahydrophthalate)	-	-	92	93970	yes	no	0.05 mg/kg		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
titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt]	-	-	805	93450	yes	no		The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w.	Details
Titanium dioxide surface-treated with fluoride-modified alumina	-	-	1077		yes	no		Only to be used at up to 25.0 % w/w, including in the nanoform.	Details
titanium dioxide reacted with octyltriethoxysilane	-	-	873	93460	yes	no		Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.	Details
tetradecyl-polyethyleneglycol(EO = 3-8) ether of glycolic acid	-	-	91	92320	yes	yes	15 mg/kg		Details
taurine, salts	-	-	90	92195	yes	no			Details
sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts	-	-	814	91815	yes	no	2 mg/kg		Details
sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts	-	-	813	91530	yes	no	5 mg/kg		Details
stearoyl-2-lactylic acid, salts	-	-	821	90810	yes	no			Details
stearic acid, esters with ethyleneglycol	-	-	89	89440	yes	no			Details
sodium monoalkyl dialkylphenoxybenzenedisulphonate	-	-	88	86880	yes	no	9 mg/kg		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
silicic acid, silylated	-	-	86	86000	yes	no			Details
silicates, natural, silanated (with the exception of asbestos)	-	-	85	85610	yes	no			Details
silicates, natural (with the exception of asbestos)	-	-	84	85601	yes	no			Details
pyrophosphorous acid	-	13445-56-2	609	83455	yes	no			Details

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