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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 1 - 50 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
albumin	-	266309-43-7	1	12310	no	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters	-	-	10	30612	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 Sorbitol	-	-	100	88320 24490	yes	no			Details
sorbitol	200-061-5	50-70-4	100	88320 24490	yes	no			Details
diethyl[[3,5-bis (1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate	213-551-9	976-56-7	1007		no	no		Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Ascorbic acid	-	-	101	36000	yes	no			Details
ascorbic acid	200-066-2	50-81-7	101	36000	yes	no			Details
(methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer	-	-	1016		yes	no		Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA. The final material shall be used at room temperature or below.	Details
polyglycerol	607-759-2	25618-55-7	1017		yes	no		To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.	Details
glucose	200-075-1	50-99-7	102	17530	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 Glycerol	-	-	103	18100 55920	yes	no			Details
glycerol	200-289-5	56-81-5	103	18100 55920	yes	no			Details
montmorillonite clay modified by dimethyldialkyl (C16-C18)ammonium chloride	-	-	1030		yes	no	0.05 mg/kg	Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below. The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food. Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Furan-2,5-dicarboxylic acid	-	-	1031		no	no	5 mg/kg	Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).	Details
furan-2,5-dicarboxylic acid	221-800-8	3238-40-2	1031		no	no	5 mg/kg	Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).	Details
1,7-octadiene	223-054-9	3710-30-3	1034		no	no	0.05 mg/kg	Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.	Details
hexadecyltrimethylammonium bromide	200-311-3	57-09-0	104	58960	yes	no	6 mg/kg		Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate	-	-	1043		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	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
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
ethylene glycol dipalmitate	210-826-5	624-03-3	1048		yes	no		Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Palmitic acid	-	-	105	22780 70400	yes	no			Details
palmitic acid	200-312-9	57-10-3	105	22780 70400	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
N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide NYLOSTAB S-EED; NYSEED	419-710-0	42774-15-2	1051		yes	no	5 mg/kg		Details
2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl-(''SPG'')	604-479-2	1455-42-1	1052		no	no	5 mg/kg	Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).	Details
fatty acids, C16-18 saturated, esters with dipentaerythritol	-	-	1053		yes	no		Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.	Details
alpha-tocopherol acetate	200-405-4	58-95-7	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
tocopherol acetate	231-710-0	7695-91-2	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)	-	147398-31-0	1059		no	no		The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000Da shall not exceed 5.0 mg/kg food.	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
ground sunflower seed hulls	-	-	1060		yes	no		Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E. The seed hulls shall be obtained from sunflower seeds that are fit for human consumption. The processing temperature of the plastic containing the additive shall not exceed 240 °C.	Details
2,4,4'-trifluorobenzophenone	813-638-7	80512-44-3	1061		no	no		Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.	Details
mixture composed of 97 % tetraethyl orthosilicate (TEOS) with CAS No 78-10-4 and 3 % hexamethyldisilazane (HMDS) with CAS No 999-97-3	-	-	1062		no	no		Only to be used for the production of recycled PET and at up to 0,12 % (w/w).	Details
2,3,3,4,4,5,5-heptafluoro-1-pentene	-	1547-26-8	1063		no	no		Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.	Details
tungsten oxide	254-413-8	39318-18-8	1064		yes	no	0.05 mg/kg	Stoichiometry: WOn, n = 2,72-2,90.	Details
mixture of methylbranched and linear C14-C18 alkanamides, derived from fatty acids	288-287-0	85711-28-0	1065		yes	no	5 mg/kg	Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.	Details
1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester	-	23985-75-3	1066		no	no	0.05 mg/kg	Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).	Details
dimethyl carbonate	210-478-4	616-38-6	1067		no	no		Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.	Details
[3-(2,3-epoxypropoxy)propyl]trimethoxy silane	219-784-2	2530-83-8	1068		no	no		Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).	Details
isobutane	200-857-2	75-28-5	1069		yes	no		Only to be used as a blowing agent.	Details
urea	200-315-5	57-13-6	107	25960	no	no			Details
Montmorillonite clay modified with hexadecyltrimethylammonium bromide	-	-	1075		yes	no		Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.	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
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
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate	222-020-0	3319-31-1	1078		yes	no	1 mg/kg	Only to be used as plasticiser to manufacture soft poly(vinyl chloride). Not to be used in contact with foods intended for infants.	Details
bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH)	283-829-2	84731-70-4	1079		yes	no	0.05 mg/kg	Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.	Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
(triethanolamine-perchlorate, sodium salt) dimer	480-340-8	156157-97-0	1080		yes	no		Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.	Details

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