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

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Showing 551 - 600 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
N,N'-dicyclohexyl-2,6-naphthalene dicarboxamide	-	153250-52-3	772	47500	yes	no	5 mg/kg		Details
α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine	604-838-3	152261-33-1	803	33535	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Not to be used in contact with alcoholic foods.	Details
2-acrylamido-2-methylpropanesulphonic acid	239-268-0	15214-89-8	617	10660	no	no	0.05 mg/kg		Details
aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate]	430-650-4	151841-65-5	771	34650	yes	no	5 mg/kg		Details
ethyleneimine	205-793-9	151-56-4	334	17005	no	no	0.01 mg/kg		Details
quartz	238-878-4	14808-60-7	616	83470	yes	no			Details
talc	238-877-9	14807-96-6	615	92080	yes	no			Details
Perchlorate	623-712-9	14797-73-0	822	71938	yes	no			Details
1,3-benzenedimethanamine	216-032-5	1477-55-0	421	13000	no	no			Details
poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)	-	147398-31-0	1059		no	no		The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000Da shall not exceed 5.0 mg/kg food.	Details
2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol CG 30-1577	411-380-6	147315-50-2	770	51700	yes	no	0.05 mg/kg		Details
alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated	604-520-4	146340-15-0	802	33105	yes	no	5 mg/kg		Details
isophthalic acid, dimethyl ester	215-951-9	1459-93-4	420	19210	no	no	0.05 mg/kg		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
2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl-(''SPG'')	604-479-2	1455-42-1	1052		no	no	5 mg/kg	Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).	Details
cristobalite	238-455-4	14464-46-1	614	45560	yes	no			Details
oxalic acid	205-634-3	144-62-7	333	22775 69920	yes	no	6 mg/kg		Details
amines, bis(hydrogenated tallow alkyl) oxidised	418-370-0	143925-92-2	768	34850	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.	Details
oleyl alcohol	205-597-3	143-28-2	332	69760	yes	no			Details
1-nonanol	205-583-7	143-08-8	331	22480	no	no			Details
lauric acid	205-582-1	143-07-7	330	63280 19470	yes	no			Details
hexanoic acid	205-550-7	142-62-1	329	59360	yes	no			Details
malonic acid	205-503-0	141-82-2	328	65040	yes	no			Details
acetic acid, ethyl ester	205-500-4	141-78-6	327	30140	yes	no			Details
2-aminoethanol	205-483-3	141-43-5	326	35170 12763	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. For indirect food contact only, behind a PET layer.	Details
acrylic acid, n-butyl ester	205-480-7	141-32-2	325	10780	no	no			Details
ricinoleic acid	205-470-2	141-22-0	324	83700	yes	yes	42 mg/kg		Details
tannic acids Gallic acid derivatives found in nutgalls, bark and other plant parts, especially oak bark.	215-753-2	1401-55-4	419	92150	yes	no		According to the JECFA specifications.	Details
acrylic acid, ethyl ester	205-438-8	140-88-5	323	11470	no	no			Details
wollastonite	237-772-5	13983-17-0	613	95905	yes	no			Details
N,N'-divinyl-2-imidazolidinone	237-457-2	13811-50-2	612	16694	no	no	0.05 mg/kg		Details
lactic acid, butyl ester	205-316-4	138-22-7	322	63040	yes	no			Details
ascorbyl palmitate	205-305-4	137-66-6	321	36080	yes	no			Details
1,2-bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine	500-311-6	136504-96-6	767	38510	yes	no	5 mg/kg		Details
benzoic acid, butyl ester	205-252-7	136-60-7	320	37680	yes	no			Details
bis(3,4-dimethylbenzylidene)sorbitol	413-110-2	135861-56-2	766	38879	yes	no			Details
3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether	236-946-8	13560-49-1	611	35120	yes	no			Details
2,4-dimethyl-6-(1-methylpentadecyl)phenol CG 27-145	411-220-5	134701-20-5	765	49485	yes	yes	1 mg/kg		Details
titanium dioxide	236-675-5	13463-67-7	610	93440	yes	no			Details
pyrophosphorous acid	-	13445-56-2	609	83455	yes	no			Details
aluminium oxide	215-691-6	1344-28-1	418	34720	yes	no			Details
silicic acid	215-683-2	1343-98-2	417	85680	yes	no			Details
sorbitan monooleate	215-665-4	1338-43-8	416	87680	yes	no			Details
sorbitan monostearate	215-664-9	1338-41-6	415	87840	yes	no			Details
sorbitan monolaurate	215-663-3	1338-39-2	414	87600	yes	no			Details
ammonium hydroxide	215-647-6	1336-21-6	413	35600	yes	no			Details
glycerol, esters with acetic acid	215-637-1	1335-58-6	40	56360	yes	no			Details
copper iodide	215-625-6	1335-23-5	412	45200	yes	no			Details
carbon black	215-609-9	1333-86-4	411	42080	yes	no		Primary particles of 10 - 300 nm which are aggregated to a size of 100 - 1200 nm which may form agglomerates within the size distribution of 300 nm - mm. Toluene extractables: maximum 0,1 %, determined according to ISO method 6209. UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis. Benzo(a)pyrene content: max 0,25 mg/kg carbon black. Maximum use level of carbon black in the polymer: 2,5 % w/w.	Details
kaolin A clay that is essentially kaolinite, a hydrated aluminum silicate. It has a high fusion point and is the most refractory of all clays.	310-194-1	1332-58-7	410	62720	yes	no		Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi- layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.	Details

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