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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 10 May 2024. Database contains 1080 unique substances/entries.

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Showing 401 - 500 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
11-aminoundecanoic acid	219-417-6	2432-99-7	443	12788	no	no	5 mg/kg		Details
1,4-butanediol bis(2,3-epoxypropyl)ether	219-371-7	2425-79-8	442	13780	no	no	0.01 mg/kg	Residual content = 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	Details
Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (BTDA)	219-348-1	2421-28-5	1083		no	no	0.05 mg/kg	Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.	Details
2,3,6-trimethylphenol	219-330-3	2416-94-6	882	25872	no	no	0.05 mg/kg		Details
benzoic acid, propyl ester	219-020-8	2315-68-6	441	38160	yes	no			Details
methacrylic acid, propyl ester	218-639-0	2210-28-8	440	21340	no	no			Details
methacrylic acid, phenyl ester	218-542-3	2177-70-0	439	21280	no	no			Details
bis(2,6-diisopropylphenyl) carbodiimide	218-487-5	2162-74-5	438	13303	no	no	0.05 mg/kg	Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline	Details
acrylic acid, dodecyl ester	218-463-4	2156-97-0	437	11245	no	no	0.05 mg/kg		Details
lauric acid, vinyl ester	218-414-7	2146-71-6	436	19480	no	no			Details
caprolactam, sodium salt	218-336-3	2123-24-2	435	14230	no	no			Details
methacrylic acid, diester with 1,4-butanediol	218-218-1	2082-81-7	434	20410	no	no	0.05 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
adipic anhydride	218-001-1	2035-75-8	432	12280	no	no			Details
linolenic acid	217-792-0	28290-79-1	663	64150	yes	no			Details
2-hydroxy-4-n-octyloxybenzophenone	217-421-2	1843-05-6	431	61600	yes	yes			Details
1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane	217-420-7	1843-03-4	430	95600	yes	yes	5 mg/kg		Details
bis(4-aminocyclohexyl)methane	217-168-8	1761-71-3	429	13210	no	no	0.05 mg/kg		Details
1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene	216-971-0	1709-70-2	428	95200	yes	no			Details
4-(hydroxymethyl)-1-cyclohexene	216-847-6	1679-51-2	427	18896	no	no	0.05 mg/kg		Details
2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether	216-823-5	1675-54-3	426	13610 13510	no	no		In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].	Details
acrylic acid, tert-butyl ester	216-768-7	1663-39-4	425	10840	no	no			Details
1,9-decadiene	216-711-6	1647-16-1	424	15070	no	no	0.05 mg/kg		Details
perfluoropropylperfluorovinyl ether	216-600-2	1623-05-8	423	22937	no	no	0.05 mg/kg		Details
4,4'-bis(2-benzoxazolyl)stilbene	216-245-3	1533-45-5	422	38515	yes	yes	0.05 mg/kg		Details
1,3-benzenedimethanamine	216-032-5	1477-55-0	421	13000	no	no			Details
isophthalic acid, dimethyl ester	215-951-9	1459-93-4	420	19210	no	no	0.05 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
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
iron oxide	215-570-8	1332-37-2	409	62240	yes	no			Details
1,2-propyleneglycol monooleate	215-549-3	1330-80-9	408	82960	yes	no			Details
sodium tetraborate	215-540-4	1330-43-4	407	87040	yes	no			Details
1,2-propyleneglycol monostearate	215-354-3	1323-39-3	406	83300	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
molybdenum disulphide	215-263-9	1317-33-5	404	67200	yes	no			Details
zinc sulphide	215-251-3	1314-98-3	403	96320	yes	no			Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	1050		yes	no		Only to be used in unplasticised polymers.	Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	402	96240	yes	no			Details
zinc oxide;zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	215-222-5	1314-13-2	1046		yes	no		Only to be used in unplasticised polymers. The restrictions and specifications specified for FCM substance No 788 shall be respected.	Details
sodium sulphide	215-211-5	1313-82-2	401	24475	no	no			Details
sodium hydroxide	215-185-5	1310-73-2	400	86720	yes	no			Details
potassium hydroxide	215-181-3	1310-58-3	399	81600	yes	no			Details
antimony trioxide	215-175-0	1309-64-4	398	35760	yes	no			Details
magnesium oxide	215-171-9	1309-48-4	397	64720	yes	no			Details
magnesium hydroxide	215-170-3	1309-42-8	396	64640	yes	no			Details
calcium oxide	215-138-9	1305-78-8	395	41520	yes	no			Details
calcium hydroxide	215-137-3	1305-62-0	394	41280	yes	no			Details
bentonite A colloidal clay. Consists primarily of montmorillonite.	215-108-5	1302-78-9	393	37280	yes	no			Details
phosphoric acid, diphenyl 2-ethylhexyl ester	214-987-2	1241-94-7	392	72800	yes	yes	2.4 mg/kg		Details
perfluoromethyl perfluorovinyl ether	214-703-7	1187-93-5	391	22932	no	no	0.05 mg/kg	Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.	Details
gallic acid, dodecyl ester	214-620-6	1166-52-5	390	55200	yes	no			Details
2,6-naphthalenedicarboxylic acid	214-527-0	1141-38-4	389	22360	no	no	5 mg/kg		Details
1-tetradecene	214-306-9	1120-36-1	388	25080	no	no	0.05 mg/kg		Details
1,4-cyclohexanedicarboxylic acid	214-068-6	1076-97-7	806	14876	no	no	5 mg/kg	Only to be used for manufacture of polyesters.	Details
1-vinylimidazole	214-012-0	1072-63-5	387	26155	no	no	0.05 mg/kg		Details
gallic acid, octyl ester	213-853-0	1034-01-1	386	55280	yes	no			Details
acrylic acid, 2-hydroxypropyl ester	213-663-8	999-61-1	385	11530	no	no	0.05 mg/kg	SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).	Details
2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine	213-590-1	991-84-4	384	40000	yes	yes	30 mg/kg		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
2-phenylindole	213-436-3	948-65-2	383	72160	yes	yes	15 mg/kg		Details
laurolactam	213-424-8	947-04-6	382	19490	no	no	5 mg/kg		Details
cyclooctene	213-245-5	931-88-4	381	15030	no	no	0.05 mg/kg	Only to be used in polymers contacting foods for which simulant A is laid down.	Details
acrylic acid, propyl ester	213-120-5	925-60-0	380	11980	no	no			Details
N-methylolacrylamide	213-103-2	924-42-5	379	21940	no	no	0.01 mg/kg		Details
N-methylolmethacrylamide	213-086-1	923-02-4	378	21970	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
N-methylpyrrolidone	212-828-1	872-50-4	376	66905	yes	no	60 mg/kg		Details
1-decene	212-819-2	872-05-9	375	15130	no	no	0.05 mg/kg		Details
methacrylic acid, monoester with ethyleneglycol	212-782-2	868-77-9	374	21190	no	no			Details
triethyl phosphonoacetate	212-757-6	867-13-0	800	94425	yes	no		Only for use in PET.	Details
2,6-naphthalenedicarboxylic acid, dimethyl ester	212-661-4	840-65-3	373	22390	no	no	0.05 mg/kg		Details
hexamethylene diisocyanate	212-485-8	822-06-0	372	18640	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
acrylic acid, monoester with ethyleneglycol	212-454-9	818-61-1	371	11830 11510	no	no			Details
methacrylic anhydride	212-084-8	760-93-0	370	21460	no	no			Details
12-aminododecanoic acid	211-754-7	693-57-2	369	12761	no	no	0.05 mg/kg		Details
thiodipropionic acid, dioctadecyl ester	211-750-5	693-36-7	368	93280	yes	yes			Details
n-dodecanedioic acid	211-746-3	693-23-2	367	16697	no	no			Details
4-methyl-1-pentene	211-720-1	691-37-2	366	22150	no	no	0.05 mg/kg		Details
acrylic acid, isopropyl ester	211-710-7	689-12-3	365	11680	no	no			Details
1,4:3,6-dianhydrosorbitol	211-492-3	652-67-5	364	15404	no	no	5 mg/kg	Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.	Details
1,10-decanediamine	211-471-9	646-25-3	863	15260	no	no	0.05 mg/kg	Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.	Details
1,3-dioxolane	211-463-5	646-06-0	363	16450	no	no	5 mg/kg		Details
carbon monoxide	211-128-3	630-08-0	362	14350	no	no			Details
1,6-hexanediol	211-074-0	629-11-8	361	18700	no	no	0.05 mg/kg		Details
ethylene glycol dipalmitate	210-826-5	624-03-3	1048		yes	no		Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.	Details
glycerol triheptanoate	210-647-2	620-67-7	360	57920	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
4,4'-dihydroxybenzophenone	210-288-1	611-99-4	359	15970 48720	yes	no			Details
4-cumylphenol	209-968-0	599-64-4	358	14841	no	no	0.05 mg/kg		Details
3-buten-2-ol	209-929-8	598-32-3	357	13932	no	no	0.01 mg/kg	Only to be used as a co-monomer for the preparation of polymeric additive.	Details
1-hexene	209-753-1	592-41-6	356	18820	no	no	3 mg/kg		Details
methacrylic acid, tert-butyl ester	209-548-7	585-07-9	355	20170	no	no			Details

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