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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 01 maj 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)
acrylic acid, n-octyl ester	219-696-4	2499-59-4	448	11890	no	no			Details
acrylic acid, propyl ester	213-120-5	925-60-0	380	11980	no	no			Details
acrylonitrile	203-466-5	107-13-1	225	12100	no	no	0.01 mg/kg		Details
adipic acid, divinyl ester	223-792-1	4074-90-2	473	12265	no	no	0.01 mg/kg	5 mg/kg in final product. Only to be used as co-monomer.	Details
adipic anhydride	218-001-1	2035-75-8	432	12280	no	no			Details
albumin	-	266309-43-7	1	12310	no	no			Details
albumin, coagulated by formaldehyde	-	-	2	12340	no	no			Details
alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)	-	-	3	12375	no	no			Details
1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane	220-666-8	2855-13-2	454	12670	no	no	6 mg/kg		Details
12-aminododecanoic acid	211-754-7	693-57-2	369	12761	no	no	0.05 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 12-Aminododecanoic acid	-	-	369	12761	no	no	0.05 mg/kg		Details
N-(2-aminoethyl)-β-alanine, sodium salt	282-811-1	84434-12-8	748	12765	no	no	0.05 mg/kg		Details
3-aminopropyltriethoxysilane	213-048-4	919-30-2	377	12786	no	no	0.05 mg/kg	Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers. SML = 0,05 mg/kg when used for the surface treatment of materials and articles.	Details
11-aminoundecanoic acid	219-417-6	2432-99-7	443	12788	no	no	5 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 11-Aminoundecanoic acid	-	-	443	12788	no	no	5 mg/kg		Details
ammonia	231-635-3	7664-41-7	510	12789 35320	yes	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Azelaic acid	-	-	302	12820	no	no			Details
azelaic acid	204-669-1	123-99-9	302	12820	no	no			Details
azelaic anhydride	-	4196-95-6	479	12970	no	no			Details
1,3-benzenedimethanamine	216-032-5	1477-55-0	421	13000	no	no			Details
1,3,5-benzenetricarboxylic acid trichloride	224-594-8	4422-95-1	481	13060	no	no	0.05 mg/kg	SML expressed as 1,3,5-benzenetricarboxylic acid.	Details
2,4-diamino-6-phenyl-1,3,5-triazine	202-095-6	91-76-9	168	13075 15310	no	no	5 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 Benzyl alcohol	-	-	194	13150	no	no			Details
benzyl alcohol	202-859-9	100-51-6	194	13150	no	no			Details
bis(4-aminocyclohexyl)methane	217-168-8	1761-71-3	429	13210	no	no	0.05 mg/kg		Details

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