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

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Showing 751 - 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)
alpha-tocopherol acetate	200-405-4	58-95-7	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
arachidic acid	208-031-3	506-30-9	345	35840	yes	no			Details
ascorbic acid	200-066-2	50-81-7	101	36000	yes	no			Details
calcium butyrate	227-265-7	5743-36-2	489	41040	yes	no			Details
caprolactone	207-938-1	502-44-3	342	14260	no	no			Details
carbonic acid, rubidium salt	209-530-9	584-09-8	353	42480	yes	no	12 mg/kg		Details
di(p-tolylidene)sorbitol	611-185-8	54686-97-4	752	39890	yes	no			Details
di-n-octyltin ethyleneglycol bis(mercaptoacetate)	260-414-4	56875-68-4	736	50960	yes	no			Details
dicyclohexylmethane-4,4'-diisocyanate	225-863-2	5124-30-1	485	15700 13560	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
dimethyltin bis(ethylhexyl mercaptoacetate)	260-829-0	57583-35-4	698	49595	yes	no			Details
diphenylmethane-2,4'-diisocyanate	227-534-9	5873-54-1	490	16600	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
ethylene-N-palmitamide-N'-stearamide	-	5136-44-7	486	54005	yes	no			Details
formaldehyde	200-001-8	50-00-0	98	17260 54880	yes	no			Details
glucose	200-075-1	50-99-7	102	17530	no	no			Details
glycerol	200-289-5	56-81-5	103	18100 55920	yes	no			Details
glycerol, esters with ricinoleic acid	261-327-4	58561-47-0	52	56580	yes	no			Details
hexadecyltrimethylammonium bromide	200-311-3	57-09-0	104	58960	yes	no	6 mg/kg		Details
lactic acid	200-018-0	50-21-5	99	19460 62960	yes	no			Details
lignoceric acid	209-180-7	557-59-5	350	63920	yes	no			Details
methacrylic acid, sulphopropyl ester	-	54276-35-6	694	21400	no	no	0.05 mg/kg		Details
methacrylic acid, tert-butyl ester	209-548-7	585-07-9	355	20170	no	no			Details
monomethyltin tris(ethylhexyl mercaptoacetate)	260-828-5	57583-34-3	697	67515	yes	no			Details
monomethyltin tris(isooctyl mercaptoacetate)	259-374-0	54849-38-6	695	67520	yes	no			Details
myristic acid	208-875-2	544-63-8	348	67891 22350	yes	no			Details
N,N'-ethylenebispalmitamide	226-864-0	5518-18-3	488	53440	yes	no			Details
palmitic acid	200-312-9	57-10-3	105	22780 70400	yes	no			Details
perfluoro[2-(poly(n-propoxy))propanoic acid]	680-272-0	51798-33-5	860	71980	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.	Details
Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate	258-053-2	52628-03-2	1082		no	no	0.05 mg/kg	Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.	Details
poly(12-hydroxystearic acid) stearate	500-140-7	58128-22-6	875	80345	yes	yes	5 mg/kg		Details
sorbitan tripalmitate	258-994-9	54140-20-4	693	88160	yes	no			Details
sorbitol	200-061-5	50-70-4	100	88320 24490	yes	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	yes	no			Details
stearoylbenzoylmethane	261-257-4	58446-52-9	699	90720	yes	no			Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)	260-815-4	57569-40-1	696	92205	yes	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
urea	200-315-5	57-13-6	107	25960	no	no			Details
(2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)	264-144-8	63438-80-2	711	42000	yes	yes	30 mg/kg		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
1,2-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
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-propyleneglycol distearate	228-229-3	6182-11-2	491	82720	yes	no			Details
1,3-dioxolane	211-463-5	646-06-0	363	16450	no	no	5 mg/kg		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
1,6-hexanediol	211-074-0	629-11-8	361	18700	no	no	0.05 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
12-aminododecanoic acid	211-754-7	693-57-2	369	12761	no	no	0.05 mg/kg		Details

Showing 751 - 800 of 1,080 results.

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