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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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Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
triallylamine	203-048-2	102-70-5	205	25385	no	no		40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. Only to be used in hydrogels intended for non-direct food contact use.	Details
trialkyl acetic acid (C7-C17), vinyl esters	-	-	6	25380	no	no	0.05 mg/kg		Details
trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester	-	-	5	25360	no	no	0.01 mg/kg	1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	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
2,4-toluene diisocyanate	209-544-5	584-84-9	354	25210	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2,4,4-Tetramethylcyclobutane-1,3-diol	-	-	881	25187	no	no	5 mg/kg	Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.	Details
2,2,4,4-tetramethylcyclobutane-1,3-diol	221-140-0	3010-96-6	881	25187	no	no	5 mg/kg	Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.	Details
tetrahydrofuran	203-726-8	109-99-9	246	25150	no	no	0.6 mg/kg		Details
tetrafluoroethylene	204-126-9	116-14-3	281	25120	no	no	0.05 mg/kg		Details
1-tetradecene	214-306-9	1120-36-1	388	25080	no	no	0.05 mg/kg		Details
terephthalic acid, dimethyl ester	204-411-8	120-61-6	288	24970	no	no			Details
terephthalic acid dichloride	202-829-5	100-20-9	191	24940	no	no			Details
terephthalic acid	202-830-0	100-21-0	785	24910	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 Terephthalic acid	-	-	785	24910	no	no			Details
syrups, hydrolysed starch, hydrogenated	270-337-8	68425-17-2	724	24903	no	no		In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].	Details
5-sulphoisophthalic acid, salts	-	-	823	24889	no	no	5 mg/kg		Details
5-sulphoisophthalic acid, monosodium salt, dimethyl ester	223-578-8	3965-55-7	471	24888	no	no	0.05 mg/kg		Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
succinic anhydride	203-570-0	108-30-5	233	24850	no	no			Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	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 Styrenesuphonic acid	-	-	656	24760	no	no	0.05 mg/kg		Details
styrene	202-851-5	100-42-5	193	24610	no	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	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 Stearic acid	-	-	106	24550 89040	yes	no			Details
starch, edible High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.	232-679-6	9005-25-8	564	24540 88800	yes	no			Details
soybean oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).	232-274-4	8001-22-7	524	24520	no	no			Details
sodium sulphide	215-211-5	1313-82-2	401	24475	no	no			Details
sebacic anhydride	219-882-5	2561-88-8	450	24430	no	no			Details
sebacic acid	203-845-5	111-20-6	260	24280	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 Sebacic acid	-	-	260	24280	no	no			Details
rosin tall oil A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.	232-484-6	8052-10-6	539	24160	no	no			Details
rosin A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.	232-475-7	8050-09-7	535	24100 24190 83840 24130	yes	no			Details
resorcinol diglycidyl ether	202-987-5	101-90-6	199	24073	no	no	0.01 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
1,3-dihydroxybenzene	203-585-2	108-46-3	237	24072 15910	no	no	2.4 mg/kg		Details
pyromellitic anhydride	201-898-9	89-32-7	166	24057	no	no	0.05 mg/kg		Details
1,2-dihydroxybenzene	204-427-5	120-80-9	289	24051 15880	no	no	6 mg/kg		Details
propylene oxide	200-879-2	75-56-9	135	24010	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
propylene	204-062-1	115-07-1	275	23980	no	no			Details
propionic anhydride	204-638-2	123-62-6	297	23950	no	no			Details
propionic acid, vinyl ester	203-293-5	105-38-4	211	23920	no	no			Details
propionaldehyde	204-623-0	123-38-6	296	23860	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
1-propanol	200-746-9	71-23-8	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 1,3-Propanediol	-	-	343	23770	no	no	0.05 mg/kg		Details
1,3-propanediol	207-997-3	504-63-2	343	23770	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 1,2-Propanediol	-	-	109	23740 81840	yes	no			Details
1,2-propanediol	200-338-0	57-55-6	109	23740 81840	yes	no			Details
polypropyleneglycol 1 - 4.5 moles propoxylated	500-039-8	25322-69-4	639	23651 80800	yes	no			Details
polyethyleneglycol 1 - 4.5 moles ethoxylated	500-038-2	25322-68-3	638	23590 76960	yes	no			Details

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