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

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Showing 251 - 300 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine	455-890-7	6607-41-6	872		no	no	0.05 mg/kg	To be used only as a co-monomer in polycarbonate copolymers.	Details
rosin, hydrogenated, ester with glycerol	266-042-9	65997-13-9	718	84240	yes	no			Details
rosin, hydrogenated	266-041-3	65997-06-0	717	84210	yes	no			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
1,4:3,6-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
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt	265-512-0	65140-91-2	715	46880	yes	no	6 mg/kg		Details
benzoic acid	200-618-2	65-85-0	116	37600 13090	yes	no			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
1,3-dioxolane	211-463-5	646-06-0	363	16450	no	no	5 mg/kg		Details
rosin, hydrogenated, ester with pentaerythritol	264-848-5	64365-17-9	714	84400	yes	no			Details
charcoal, activated	264-846-4	64365-11-3	713	43480	yes	no		Only for use in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).	Details
terephthalic acid, bis(2-ethylhexyl)ester	229-176-9	6422-86-2	798	92200	yes	no	60 mg/kg		Details
terephthalic acid, bis(2-ethylhexyl)ester	229-176-9	6422-86-2	798	92200	yes	no			Details
castor oil, dehydrated	264-705-7	64147-40-6	712	42960	yes	no			Details
acetic acid	200-580-7	64-19-7	115	30000 10090	yes	no			Details
formic acid	200-579-1	64-18-6	114	55040	yes	no			Details
ethanol	200-578-6	64-17-5	113	52800 16780	yes	no			Details
(2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)	264-144-8	63438-80-2	711	42000	yes	yes	30 mg/kg		Details
bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)	264-122-8	63397-60-4	710	38700	yes	yes	18 mg/kg		Details
polydimethylsiloxane (Mw > 6800 Da)	613-156-5	63148-62-9	575	76721	yes	no		Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).	Details
hypophosphorous acid	228-601-5	6303-21-5	494	62140	yes	no			Details
carbon monoxide	211-128-3	630-08-0	362	14350	no	no			Details
1,6-hexanediol	211-074-0	629-11-8	361	18700	no	no	0.05 mg/kg		Details
sorbitan monobehenate	263-600-3	62568-11-0	709	87520	yes	no			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
bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride	228-253-4	6200-40-4	493	39200	yes	no	1.8 mg/kg		Details
glycerol triheptanoate	210-647-2	620-67-7	360	57920	yes	no			Details
2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester	228-250-8	6197-30-4	492	45650	yes	no	0.05 mg/kg		Details
1,2-propyleneglycol distearate	228-229-3	6182-11-2	491	82720	yes	no			Details
polyethyleneglycol ester of castor oil 1 - 6.5 moles ethoxylated	500-151-7	61791-12-6	708	77520	yes	no	42 mg/kg		Details
diatomaceous earth	612-383-7	61790-53-2	707	46375	yes	no			Details
fatty acids, tall oil	263-107-3	61790-12-3	706	17230	no	no			Details
acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled	500-148-0	61788-89-4	705	10599/91 10599/90A	no	no			Details
polyethyleneglycol ester of hydrogenated castor oil 1 - 6.5 moles ethoxylated	500-147-5	61788-85-0	704	77600	yes	no			Details
fatty acids, coco	262-978-7	61788-47-4	703	17170	no	no			Details
sorbitan tetrastearate	262-958-8	61752-68-9	702	87920	yes	no			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
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer	-	61269-61-2	701	40160	yes	no	2.4 mg/kg		Details
acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester	262-634-6	61167-58-6	700	31520	yes	yes	6 mg/kg		Details
4,4'-dihydroxybenzophenone	210-288-1	611-99-4	359	15970 48720	yes	no			Details
linoleic acid	200-470-9	60-33-3	112	64015	yes	no			Details
ethylenediaminetetraacetic acid	200-449-4	60-00-4	111	53600	yes	no			Details
4-cumylphenol	209-968-0	599-64-4	358	14841	no	no	0.05 mg/kg		Details
3-buten-2-ol	209-929-8	598-32-3	357	13932	no	no	0.01 mg/kg	Only to be used as a co-monomer for the preparation of polymeric additive.	Details
1-hexene	209-753-1	592-41-6	356	18820	no	no	3 mg/kg		Details
alpha-tocopherol	200-412-2	59-02-9	110	93520	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
glycerol, esters with ricinoleic acid	261-327-4	58561-47-0	52	56580	yes	no			Details
methacrylic acid, tert-butyl ester	209-548-7	585-07-9	355	20170	no	no			Details
stearoylbenzoylmethane	261-257-4	58446-52-9	699	90720	yes	no			Details

Showing 251 - 300 of 1,080 results.

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