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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 201 - 250 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
ethylene	200-815-3	74-85-1	125	16950	no	no			Details
glycerides, castor-oil mono-, hydrogenated, acetates	451-530-8	736150-63-3	783	55910	yes	no			Details
resin acids and rosin acids	277-299-1	73138-82-6	741	83610 24070	yes	no			Details
polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol	843-673-3	73018-26-5	797	76807	yes	yes			Details
polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol	843-673-3	73018-26-5	797	76807	yes	yes			Details
poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]	615-678-9	71878-19-8	740	81200	yes	yes	3 mg/kg		Details
2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene	230-426-4	7128-64-5	500	38560	yes	yes	0.6 mg/kg		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
2,2'-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	274-572-7	70331-94-1	739	70000	yes	no			Details
2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole	274-570-6	70321-86-7	738	60320	yes	yes	1.5 mg/kg		Details
polyethyleneglycol-30 dipolyhydroxystearate	680-598-3	70142-34-6	737	77370	yes	no			Details
12-aminododecanoic acid	211-754-7	693-57-2	369	12761	no	no	0.05 mg/kg		Details
thiodipropionic acid, dioctadecyl ester	211-750-5	693-36-7	368	93280	yes	yes			Details
n-dodecanedioic acid	211-746-3	693-23-2	367	16697	no	no			Details
di-n-octyltin 1,4-butanediol bis(mercaptoacetate)	-	69226-46-6	30	50560	yes	no			Details
bis(methylbenzylidene)sorbitol	-	69158-41-4	752	39890	yes	no			Details
malic acid	230-022-8	6915-15-7	499	19965 65020	yes	no		In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.	Details
4-methyl-1-pentene	211-720-1	691-37-2	366	22150	no	no	0.05 mg/kg		Details
bis(polyethyleneglycol)hydroxymethylphosphonate	614-830-1	68951-50-8	735	40120	yes	no	0.6 mg/kg		Details
acrylic acid, isopropyl ester	211-710-7	689-12-3	365	11680	no	no			Details
diatomaceous earth, soda ash flux-calcined	272-489-0	68855-54-9	734	46380	yes	no			Details
acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled	500-231-1	68783-41-5	733	10599/93 10599/92A	no	no			Details
3,3'-dimethyl-4,4'-diaminodicyclohexylmethane	229-962-1	6864-37-5	498	16210	no	no	0.05 mg/kg	Only to be used in polyamides.	Details
p-cresol-dicyclopentadiene-isobutylene, copolymer	271-867-2	68610-51-5	732	45450	yes	yes	5 mg/kg		Details
N-heptylaminoundecanoic acid	271-487-7	68564-88-5	731	18220	no	no	0.05 mg/kg		Details
methylsilsesquioxane	614-610-5	68554-70-1	730	66930	yes	no		Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.	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
2,2,4-trimethyl-1,3-pentanediol diisobutyrate	229-934-9	6846-50-0	497	95020	yes	no	5 mg/kg	Only to be used in single-use gloves.	Details
cellulose, regenerated The product obtained by treating cellulose with caustic soda, reacting this with carbon disulfide, dissolving this in a dilute alkali solution and extruding into an acid to form a continuous viscose tube.	270-493-7	68442-85-3	727	43360	yes	no			Details
reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin	270-476-4	68442-12-6	726	83599	yes	yes			Details
polyethylene waxes, oxidised	614-498-8	68441-17-8	811	80077	yes	no	60 mg/kg		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
starch, hydrolysed	686-629-7	68412-29-3	723	88880	yes	no			Details
fatty acids, soya	269-657-0	68308-53-2	722	17200	no	no			Details
di-n-octyltin bis(ethyl maleate)	268-500-3	68109-88-6	29	50360	yes	no			Details
3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester	267-342-2	67845-93-6	721	46800	yes	no			Details
mono-n-dodecyltin tris(isooctyl mercaptoacetate)	266-836-5	67649-65-4	720	67360	yes	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
pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	229-722-6	6683-19-8	496	71680	yes	no			Details
N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers	-	66822-60-4	719	65920	yes	no			Details
6-amino-1,3-dimethyluracil	229-662-0	6642-31-5	495	35160	yes	no	5 mg/kg		Details
polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane	-	661476-41-1	782	76725	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).	Details

Showing 201 - 250 of 1,080 results.

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