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

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Showing 1 - 50 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
thiodipropionic acid, dioctadecyl ester	211-750-5	693-36-7	368	93280	yes	yes			Details
thiodipropionic acid, didodecyl ester	204-614-1	123-28-4	294	93120	yes	yes			Details
thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)	255-392-8	41484-35-9	690	92880	yes	yes	2.4 mg/kg		Details
tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-biphenylylene diphosphonite	254-037-4	38613-77-3	688	92560	yes	yes	18 mg/kg		Details
tetradecyl-polyethyleneglycol(EO = 3-8) ether of glycolic acid	-	-	91	92320	yes	yes	15 mg/kg		Details
salicylic acid, 4-tert-butylphenyl ester	201-728-3	87-18-3	160	84800	yes	yes	12 mg/kg		Details
ricinoleic acid	205-470-2	141-22-0	324	83700	yes	yes	42 mg/kg		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
polyethyleneglycol monoricinoleate	618-404-6	9004-97-1	563	78320	yes	yes	42 mg/kg		Details
polyethyleneglycol diricinoleate	-	-	74	77440	yes	yes	42 mg/kg		Details
polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol (Group Restriction No: 32)	-	-	73	76866	yes	yes			Details
polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol	-	-	73	76866	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
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
poly(12-hydroxystearic acid) stearate	500-140-7	58128-22-6	875	80345	yes	yes	5 mg/kg		Details
phosphorous acid, tris(nonyl-and/or dinonylphenyl) ester	-	-	69	74400	yes	yes	30 mg/kg		Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	10 mg/kg	SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.	Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	1 mg/kg	The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.	Details
phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester IRGAFOS 38	416-140-4	145650-60-8	769	74010	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	Details
phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters	-	-	68	73160	yes	yes	0.05 mg/kg		Details
phosphoric acid, diphenyl 2-ethylhexyl ester	214-987-2	1241-94-7	392	72800	yes	yes	2.4 mg/kg		Details
pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)	429-160-3	178671-58-4	778	71670	yes	yes	0.05 mg/kg		Details
p-cresol-dicyclopentadiene-isobutylene, copolymer	271-867-2	68610-51-5	732	45450	yes	yes	5 mg/kg		Details
oleylpalmitamide	240-367-6	16260-09-6	622	69840	yes	yes	5 mg/kg		Details
octadecylerucamide	233-226-5	10094-45-8	587	68400	yes	yes	5 mg/kg		Details
octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate	218-216-0	2082-79-3	433	68320	yes	yes	6 mg/kg		Details
N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione	-	852282-89-4	809	49080	yes	yes	0.05 mg/kg	Only for use in PET.	Details
N,N'-diphenylthiourea	203-004-2	102-08-9	200	51680	yes	yes	3 mg/kg		Details
N,N'-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide	251-156-3	32687-78-8	675	38800	yes	yes	15 mg/kg		Details
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
dioctadecyl disulphide	219-702-5	2500-88-1	449	49840	yes	yes	0.05 mg/kg		Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
di-n-dodecyltin bis(isooctyl mercaptoacetate)	281-837-0	84030-61-5	747	47600	yes	yes			Details
bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)	264-122-8	63397-60-4	710	38700	yes	yes	18 mg/kg		Details
bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite ADK STAB PEP-36	410-290-4	80693-00-1	746	38810	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	Details
bis(2,4-dicumylphenyl)pentaerythritol-diphosphite	421-920-2	154862-43-8	773	38840	yes	yes	5 mg/kg	SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol).	Details
bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	247-952-5	26741-53-7	652	38820	yes	yes	0.6 mg/kg		Details
benzophenone	204-337-6	119-61-9	286	38240	yes	yes	0.6 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Ricinoleic acid	-	-	324	83700	yes	yes	42 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 4,4'-Thiobis(6-tert-butyl-3-methylphenol)	-	-	178	92800	yes	yes	0.48 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,6-Di-tert-butyl-4-ethylphenol	-	-	477	46720	yes	yes	4.8 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,4-Dimethyl-6-(1-methylpentadecyl)phenol	-	-	765	49485	yes	yes	1 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,4-Bis(octylthiomethyl)-6-methylphenol	-	-	756	40020	yes	yes			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,4-Bis(dodecylthiomethyl)-6-methylphenol	-	-	758	38940	yes	yes			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	-	-	472	66560	yes	yes			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2'-Methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	-	-	137	66580	yes	yes			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2'-Methylene bis(4-methyl-6-tert-butylphenol)	-	-	285	66480	yes	yes			Details
alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines	-	-	15	34130	yes	yes	30 mg/kg		Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes			Details

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