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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 23 April 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)
2,2'-methylene bis(4-methyl-6-tert-butylphenol)	204-327-1	119-47-1	285	66480	yes	yes			Details
2,2'-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	201-044-5	77-62-3	137	66580	yes	yes			Details
2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	223-773-8	4066-02-8	472	66560	yes	yes			Details
2,2'-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	274-572-7	70331-94-1	739	70000	yes	no			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
2,3,3,4,4,5,5-heptafluoro-1-pentene	-	1547-26-8	1063		no	no		Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.	Details
2,4,4'-trifluorobenzophenone	813-638-7	80512-44-3	1061		no	no		Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.	Details
2,4-bis(dodecylthiomethyl)-6-methylphenol	438-600-3	110675-26-8	758	38940	yes	yes			Details
2,4-bis(octylthiomethyl)-6-methylphenol CG 25-1320; IRGANOX 1520; TK 12229/1	402-860-6	110553-27-0	756	40020	yes	yes			Details
2,4-dihydroxybenzophenone	205-029-4	131-56-6	318	48640	yes	no			Details
2,4-toluene diisocyanate	209-544-5	584-84-9	354	25210	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
2,4-toluene diisocyanate dimer	247-953-0	26747-90-0	653	25270	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
2,6-toluene diisocyanate	202-039-0	91-08-7	167	25240	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
2-(2'-hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazole	223-445-4	3896-11-5	470	60400	yes	yes			Details
2-(2'-hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole	223-383-8	3864-99-1	469	60480	yes	yes			Details
2-(2'-hydroxy-5'-methylphenyl)benzotriazole	219-470-5	2440-22-4	444	61440	yes	no			Details
2-butene	203-452-9	107-01-7	224	13900	no	no			Details
2-hydroxy-4-methoxybenzophenone	205-031-5	131-57-7	319	61360	yes	yes			Details
2-hydroxy-4-n-hexyloxybenzophenone	-	3293-97-8	464	61280	yes	yes			Details
2-hydroxy-4-n-octyloxybenzophenone	217-421-2	1843-05-6	431	61600	yes	yes			Details
2-propanol	200-661-7	67-63-0	118	81882 23830	yes	no			Details
2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]	-	37486-69-4	903		yes	no		Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.	Details
3,3'-dimethyl-4,4'-diisocyanatobiphenyl	202-112-7	91-97-4	169	16240	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
3,5-di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester	224-166-0	4221-80-1	480	46790	yes	no			Details
3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester	267-342-2	67845-93-6	721	46800	yes	no			Details
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester	221-532-1	3135-18-0	459	46870	yes	no			Details
3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether	236-946-8	13560-49-1	611	35120	yes	no			Details
3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer	616-996-0	80181-31-3	744	18888	no	no		The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.	Details
3H-perfluoro-3-[(3-methoxy-propoxy) propanoic acid], ammonium salt	-	958445-44-8	896	71958	yes	no		Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.	Details
4,4'-dihydroxybenzophenone	210-288-1	611-99-4	359	15970 48720	yes	no			Details
4-hydroxybenzoic acid, ethyl ester	204-399-4	120-47-8	287	60160	yes	no			Details
4-hydroxybenzoic acid, isopropyl ester	224-069-3	4191-73-5	478	60180	yes	no			Details
4-hydroxybenzoic acid, methyl ester	202-785-7	99-76-3	189	60200	yes	no			Details
4-hydroxybenzoic acid, propyl ester	202-307-7	94-13-3	173	60240	yes	no			Details
7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin	222-067-7	3333-62-8	465	68040	yes	no			Details
[3-(2,3-epoxypropoxy)propyl]trimethoxy silane	219-784-2	2530-83-8	1068		no	no		Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).	Details
abietic acid	208-178-3	514-10-3	346	10030	no	no			Details
acetaldehyde	200-836-8	75-07-0	128	10060	no	no			Details
acetic acid	200-580-7	64-19-7	115	30000 10090	yes	no			Details
acetic acid, butyl ester	204-658-1	123-86-4	300	30045	yes	no			Details
acetic acid, ethyl ester	205-500-4	141-78-6	327	30140	yes	no			Details
acetic anhydride	203-564-8	108-24-7	232	30280 10150	yes	no			Details
acetone	200-662-2	67-64-1	119	30295	yes	no			Details
acetylacetic acid, salts	-	-	7	30370	yes	no			Details
acetylated mono- and diglycerides of fatty acids	-	-	8	30401	yes	no			Details
acetylene	200-816-9	74-86-2	126	10210	no	no			Details
acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol	-	-	11	30960	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included)	-	-	9	30610	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt	-	-	801	30607	yes	no			Details
acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters	-	-	10	30612	yes	no			Details
acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22)	-	-	879	31336	yes	no			Details
acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22)	-	-	878	31335	yes	no			Details
acids, fatty (C8-C22), esters with pentaerythritol	-	-	880	31348	yes	no			Details
acids, fatty, from animal or vegetable food fats and oils	-	-	12	31328	yes	no			Details
acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled	500-231-1	68783-41-5	733	10599/93 10599/92A	no	no			Details
acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled	500-148-0	61788-89-4	705	10599/91 10599/90A	no	no			Details
acrylic acid	201-177-9	79-10-7	147	10690	no	no			Details
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no			Details
acrylic acid, benzyl ester	219-673-9	2495-35-4	446	10750	no	no			Details
acrylic acid, ethyl ester	205-438-8	140-88-5	323	11470	no	no			Details
acrylic acid, isobutyl ester	203-417-8	106-63-8	218	11590	no	no			Details
acrylic acid, isopropyl ester	211-710-7	689-12-3	365	11680	no	no			Details
acrylic acid, methyl ester	202-500-6	96-33-3	176	11710	no	no			Details
acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters	-	174254-23-0	777	31542	yes	no		0,5 % in final product.	Details
acrylic acid, monoester with ethyleneglycol	212-454-9	818-61-1	371	11830 11510	no	no			Details
acrylic acid, n-butyl ester	205-480-7	141-32-2	325	10780	no	no			Details
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
acrylic acid, sec-butyl ester	221-072-1	2998-08-5	456	10810	no	no			Details
acrylic acid, tert-butyl ester	216-768-7	1663-39-4	425	10840	no	no			Details
adipic acid	204-673-3	124-04-9	303	31730 12130	yes	no			Details
adipic acid, bis(2-ethylhexyl) ester	203-090-1	103-23-1	207	31920	yes	yes			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
alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)	-	-	13	33120	yes	no			Details
alginic acid	232-680-1	9005-32-7	566	33350	yes	no			Details
alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms	-	-	17	34281	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 (1,3:2,4) diparamethyldibenylidene sorbitol	-	-	752	39890	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 1,2-Propanediol	-	-	109	23740 81840	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 1-Butanol	-	-	123	13840	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Decanol	-	-	267	15100	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Hexadecanol	-	-	681	18310	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Nonanol	-	-	331	22480	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Octanol	-	-	265	22600	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Pentanol	-	-	124	22870	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1-Propanol	-	-	122	23800	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 12-Hydroxystearic acid	-	-	214	61840	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 2,2'-Methylene bis(4-methyl-6-tert-butylphenol)	-	-	285	66480	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'-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 2,4-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 2,4-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-Propanol	-	-	118	81882 23830	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 Abietic acid	-	-	346	10030	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Acetic acid	-	-	115	30000 10090	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 Acrylic acid	-	-	147	10690	no	no			Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Adipic acid	-	-	303	31730 12130	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 Alginic acid	-	-	566	33350	yes	no			Details

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