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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 1,001 - 1,080 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane	223-861-6	4098-71-9	475	19110	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
1-hexene	209-753-1	592-41-6	356	18820	no	no	3 mg/kg		Details
1-hexadecanol	253-149-0	36653-82-4	681	18310	no	no			Details
1-dodecene	203-968-4	112-41-4	268	16704	no	no	0.05 mg/kg		Details
1-decene	212-819-2	872-05-9	375	15130	no	no	0.05 mg/kg		Details
1-decanol	203-956-9	112-30-1	267	15100	no	no			Details
1-butene	203-449-2	106-98-9	222	13870	no	no			Details
1-butanol	200-751-6	71-36-3	123	13840	no	no			Details
1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane	220-666-8	2855-13-2	454	12670	no	no	6 mg/kg		Details
1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride	223-805-0	4080-31-3	474	43600	yes	no	0.3 mg/kg		Details
1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer	613-797-0	65447-77-0	716	60800	yes	no	30 mg/kg		Details
1,9-decadiene	216-711-6	1647-16-1	424	15070	no	no	0.05 mg/kg		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
1,6-hexanediol	211-074-0	629-11-8	361	18700	no	no	0.05 mg/kg		Details
1,6-hexanediamine, N1,N6-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymer with 2,4-dichloro-6-(4-morpholinyl)-1,3,5-triazine	617-335-9	82451-48-7	790	80480	yes	no	5 mg/kg	Average molecular weight not less than 2400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.	Details
1,5-naphthalene diisocyanate	221-641-4	3173-72-6	461	22420	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
1,4:3,6-dianhydrosorbitol	211-492-3	652-67-5	364	15404	no	no	5 mg/kg	Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.	Details
1,4-dihydroxybenzene	204-617-8	123-31-9	295	48620 15940 18867	yes	no	0.6 mg/kg		Details
1,4-dichlorobenzene	203-400-5	106-46-7	217	15565	no	no	12 mg/kg		Details
1,4-diaminobutane	203-782-3	110-60-1	253	15250	no	no			Details
1,4-cyclohexanedicarboxylic acid	214-068-6	1076-97-7	806	14876	no	no	5 mg/kg	Only to be used for manufacture of polyesters.	Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no			Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no	0.05 mg/kg		Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no			Details
1,4-butanediol bis(2,3-epoxypropyl)ether	219-371-7	2425-79-8	442	13780	no	no	0.01 mg/kg	Residual content = 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	Details
1,4-butanediol	203-786-5	110-63-4	254	40580 13720	yes	no			Details
1,4-bis(hydroxymethyl)cyclohexane	203-268-9	105-08-8	210	13390 14880	no	no			Details
1,3-propanediol	207-997-3	504-63-2	343	23770	no	no	0.05 mg/kg		Details
1,3-phenylenediamine	203-584-7	108-45-2	236	23050	no	no	0.01 mg/kg		Details
1,3-dioxolane	211-463-5	646-06-0	363	16450	no	no	5 mg/kg		Details
1,3-dihydroxybenzene	203-585-2	108-46-3	237	24072 15910	no	no	2.4 mg/kg		Details
1,3-butanediol	203-529-7	107-88-0	228	13690	no	no			Details
1,3-bis(isocyanatomethyl)benzene	222-852-4	3634-83-1	988		no	no		SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine. To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.	Details
1,3-bis(2-hydroxyethoxy)benzene	203-028-3	102-40-9	203	13323	no	no	0.05 mg/kg		Details
1,3-benzenedimethanamine	216-032-5	1477-55-0	421	13000	no	no			Details
1,3,5-tris(4-benzoylphenyl) benzene	-	227099-60-7	781	95265	yes	no	0.05 mg/kg		Details
1,3,5-tris (2,2-dimethylpropanamido)benzene	456-830-2	745070-61-5	784	95420	yes	no	5 mg/kg		Details
1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene	216-971-0	1709-70-2	428	95200	yes	no			Details
1,3,5-benzenetricarboxylic acid trichloride	224-594-8	4422-95-1	481	13060	no	no	0.05 mg/kg	SML expressed as 1,3,5-benzenetricarboxylic acid.	Details
1,2-propyleneglycol monostearate	215-354-3	1323-39-3	406	83300	yes	no			Details
1,2-propyleneglycol monopalmitate	249-369-1	29013-28-3	665	83120	yes	no			Details
1,2-propyleneglycol monooleate	215-549-3	1330-80-9	408	82960	yes	no			Details
1,2-propyleneglycol monolaurate	248-315-4	27194-74-7	659	82800	yes	no			Details
1,2-propyleneglycol distearate	228-229-3	6182-11-2	491	82720	yes	no			Details
1,2-propyleneglycol dipalmitate	251-581-4	33587-20-1	677	82560	yes	no			Details
1,2-propyleneglycol dioleate	203-315-3	105-62-4	213	82400	yes	no			Details
1,2-propyleneglycol dilaurate	245-217-3	22788-19-8	630	82240	yes	no			Details
1,2-propyleneglycol alginate	618-414-0	9005-37-2	567	82080	yes	no			Details
1,2-propanediol	200-338-0	57-55-6	109	23740 81840	yes	no			Details
1,2-dihydroxybenzene	204-427-5	120-80-9	289	24051 15880	no	no	6 mg/kg		Details
1,2-cyclohexanedicarboxylic acid, diisononyl ester	431-890-2	166412-78-8	775	45705	yes	no			Details
1,2-bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine	500-311-6	136504-96-6	767	38510	yes	no	5 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
1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich	271-091-4	68515-49-1	729	75105	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 as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich	271-091-4	68515-49-1	729	75105	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 as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich	271-090-9	68515-48-0	728	75100	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. Not to be used in combination with FCM substances 157, 159, 283, or 1085.	Details
1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich	271-090-9	68515-48-0	728	75100	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. Not to be used in combination with FCM substances 157, 159, 283, or 1085.	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
1,10-decanediamine	211-471-9	646-25-3	863	15260	no	no	0.05 mg/kg	Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.	Details
1,1-difluoroethane	200-866-1	75-37-6	131	48460	yes	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
1,1,1-trimethylolpropane trimethacrylate	221-950-4	3290-92-4	463	25840	no	no	0.05 mg/kg		Details
1,1,1-trimethylolpropane	201-074-9	77-99-6	141	94960 25600 13380	yes	no	6 mg/kg		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
(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
(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer	-	-	979	79987	yes	no		Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.	Details
(perfluorobutyl)ethylene	243-053-7	19430-93-4	973	22931	no	no		Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.	Details
(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer	-	37953-21-2	857	66765	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.	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
(ethyl acrylate, methyl methacrylate) copolymer	618-459-6	9010-88-2	868	53245	yes	no		Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.	Details
(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer	-	40471-03-2	867	40815	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.	Details
(butyl acrylate, methyl methacrylate, styrene) copolymer	608-050-0	27136-15-8	869	66763	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.	Details
(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer	607-698-1	25322-99-0	865	40619	yes	no		Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.	Details
(butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate	-	-	866	40620	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.	Details
(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate	-	-	855	40560	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked	-	-	998		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 1043, 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
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene	-	-	859		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 998 and/or the substance with FCM No 1043, 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
(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
(1,3:2,4) diparamethyldibenylidene sorbitol	617-241-8	81541-12-0	752	39890	yes	no			Details
(1,3-phenylenedioxy)diacetic acid	203-027-8	102-39-6	202	23070	no	no	0.05 mg/kg		Details

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