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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 501 - 550 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 glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]	251-073-2	32509-66-3	673	53670	yes	yes	6 mg/kg		Details
ethylene carbonate	202-510-0	96-49-1	177	16955	no	no	30 mg/kg	SML expressed as ethyleneglycol. Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.	Details
ethylene	200-815-3	74-85-1	125	16950	no	no			Details
ethylcellulose	618-384-9	9004-57-3	555	53280	yes	no			Details
ethylcarboxymethylcellulose	-	37205-99-5	682	53270	yes	no			Details
ethanol	200-578-6	64-17-5	113	52800 16780	yes	no			Details
erucic acid	204-011-3	112-86-7	273	52730	yes	no			Details
erucamide	204-009-2	112-84-5	271	52720	yes	no			Details
epichlorohydrin	203-439-8	106-89-8	219	14570 16750	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
dolomite	240-440-2	16389-88-1	623	52640	yes	no			Details
dodecylbenzenesulphonic acid	248-289-4	27176-87-0	658	52000	yes	no	30 mg/kg		Details
dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene	-	287916-86-3	871		yes	no		Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.	Details
DL-alpha-tocopherol	233-466-0	10191-41-0	110	93520	yes	no			Details
divinylbenzene	215-325-5	1321-74-0	405	16690	no	no	0.01 mg/kg	SML expressed as the sum of divinylbenzene and ethylvinylbenzene. It may contain up to 45 % (m/m) of ethylvinylbenzene	Details
dipropyleneglycol	246-770-3	25265-71-8	257	16660 13550 51760	yes	no			Details
dipropyleneglycol	203-821-4	110-98-5	257	16660 13550 51760	yes	no			Details
diphenylmethane-4,4'-diisocyanate	202-966-0	101-68-8	198	16630	no	no		1 mg/kg in final product expressed as isocyanate moiety.	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
diphenylether-4,4'-diisocyanate	626-593-1	4128-73-8	476	16570	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
diphenyl sulphone	204-853-1	127-63-9	313	51570 16650	yes	no	3 mg/kg		Details
diphenyl carbonate	203-005-8	102-09-0	201	16540	no	no	0.05 mg/kg		Details
dipentaerythritol	204-794-1	126-58-9	311	51200 16480	yes	no			Details
dioctadecyl disulphide	219-702-5	2500-88-1	449	49840	yes	yes	0.05 mg/kg		Details
dimethyltin bis(isooctyl mercaptoacetate)	247-862-6	26636-01-1	650	49600	yes	no			Details
dimethyltin bis(ethylhexyl mercaptoacetate)	260-829-0	57583-35-4	698	49595	yes	no			Details
dimethylaminoethanol	203-542-8	108-01-0	230	16150	no	no	18 mg/kg		Details
dimethyl sulphoxide	200-664-3	67-68-5	120	49540	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
diisononyl phthalate	249-079-5	28553-12-0	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
diisononyl phthalate	249-079-5	28553-12-0	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
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
diethylenetriamine	203-865-4	111-40-0	261	15790	no	no	5 mg/kg		Details
diethyleneglycol	203-872-2	111-46-6	263	47680 13326 15760	yes	no			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
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
dicyanodiamide	207-312-8	461-58-5	340	47440	yes	no	60 mg/kg		Details
dibutylthiostannoic acid polymer	-	26427-07-6	649	47210	yes	no		Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).	Details
dibenzylidene sorbitol	251-136-4	32647-67-9	674	46480	yes	no			Details
diatomaceous earth, soda ash flux-calcined	272-489-0	68855-54-9	734	46380	yes	no			Details
diatomaceous earth	612-383-7	61790-53-2	707	46375	yes	no			Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate	-	-	33	51120	yes	no			Details
di-n-octyltin mercaptoacetate	239-581-2	15535-79-2	618	51040	yes	no			Details
di-n-octyltin ethyleneglycol bis(mercaptoacetate)	260-414-4	56875-68-4	736	50960	yes	no			Details
di-n-octyltin dimaleate, polymers (n = 2-4)	-	-	32	50880	yes	no			Details
di-n-octyltin dimaleate, esterified	-	-	31	50800	yes	no			Details
di-n-octyltin dimaleate	239-625-0	15571-60-5	620	50720	yes	no			Details
di-n-octyltin dilaurate	222-883-3	3648-18-8	466	50640	yes	no			Details
di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)	-	-	28	50160	yes	no			Details

Showing 501 - 550 of 1,080 results.

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