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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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Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
sucrose	200-334-9	57-50-1	108	24880	no	no			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
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
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
trialkyl acetic acid (C7-C17), vinyl esters	-	-	6	25380	no	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
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
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	no	0.05 mg/kg		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
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
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
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
α-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl) propylsilyl polydimethylsiloxane	641-029-4	156065-00-8	874	16265	no	no	0.05 mg/kg	Only to be used as comonomer in siloxane modified polycarbonate. The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).	Details
α-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl) propylsilyl polydimethylsiloxane	641-029-4	156065-00-8	874	16265	no	no		Only to be used as comonomer in siloxane modified polycarbonate. The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).	Details
α-methylstyrene	202-705-0	98-83-9	187	22210	no	no	0.05 mg/kg		Details
α-pinene	201-291-9	80-56-8	155	23470	no	no			Details
β-pinene	204-872-5	127-91-3	314	23500	no	no			Details
(1,3:2,4) diparamethyldibenylidene sorbitol	617-241-8	81541-12-0	752	39890	yes	no			Details
(2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)	264-144-8	63438-80-2	711	42000	yes	yes	30 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
(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 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, 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
(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
(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, 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 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
(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
(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
(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
(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
(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
1,1,1-trimethylolpropane	201-074-9	77-99-6	141	94960 25600 13380	yes	no	6 mg/kg		Details
1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane	217-420-7	1843-03-4	430	95600	yes	yes	5 mg/kg		Details
1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane	252-816-3	35958-30-6	679	39060	yes	yes	5 mg/kg		Details
1,1-difluoroethane	200-866-1	75-37-6	131	48460	yes	no			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-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

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