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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 17 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)
di-n-octyltin bis(2-ethylhexyl maleate)	233-117-2	10039-33-5	582	50240	yes	no			Details
di-n-octyltin bis(2-ethylhexyl mercaptoacetate)	239-622-4	15571-58-1	619	50320	yes	no			Details
di-n-octyltin bis(ethyl maleate)	268-500-3	68109-88-6	29	50360	yes	no			Details
di-n-octyltin bis(isooctyl maleate)	251-576-7	33568-99-9	676	50400	yes	no			Details
di-n-octyltin bis(isooctyl mercaptoacetate)	247-666-0	26401-97-8	646	50480	yes	no			Details
di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)	-	-	28	50160	yes	no			Details
di-n-octyltin dilaurate	222-883-3	3648-18-8	466	50640	yes	no			Details
di-n-octyltin dimaleate	239-625-0	15571-60-5	620	50720	yes	no			Details
di-n-octyltin dimaleate, esterified	-	-	31	50800	yes	no			Details
di-n-octyltin dimaleate, polymers (n = 2-4)	-	-	32	50880	yes	no			Details
di-n-octyltin ethyleneglycol bis(mercaptoacetate)	260-414-4	56875-68-4	736	50960	yes	no			Details
di-n-octyltin mercaptoacetate	239-581-2	15535-79-2	618	51040	yes	no			Details
di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate	-	-	33	51120	yes	no			Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
diatomaceous earth	612-383-7	61790-53-2	707	46375	yes	no			Details
diatomaceous earth, soda ash flux-calcined	272-489-0	68855-54-9	734	46380	yes	no			Details
dibenzylidene sorbitol	251-136-4	32647-67-9	674	46480	yes	no			Details
dibutylthiostannoic acid polymer	-	26427-07-6	649	47210	yes	no		Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).	Details
dicyanodiamide	207-312-8	461-58-5	340	47440	yes	no	60 mg/kg		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
diethyl[[3,5-bis (1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate	213-551-9	976-56-7	1007		no	no		Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)	Details
diethyleneglycol	203-872-2	111-46-6	263	47680 13326 15760	yes	no			Details
diethylenetriamine	203-865-4	111-40-0	261	15790	no	no	5 mg/kg		Details
diisodecyl phthalate	247-977-1	26761-40-0	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
diisodecyl phthalate	247-977-1	26761-40-0	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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