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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 51 - 100 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
polypropylene wax	618-352-4	9003-07-0	550	81060	yes	no			Details
polyethylene wax	618-339-3	9002-88-4	549	80000	yes	no			Details
carboxymethylcellulose	618-326-2	9000-11-7	542	42640	yes	no			Details
bis(4-propylbenzylidene)propylsorbitol	618-128-6	882073-43-0	808	38550	yes	no	5 mg/kg	SML including the sum of its hydrolysis products.	Details
2,2'-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate	617-688-9	85209-93-4	750	66350	yes	no	5 mg/kg		Details
1,6-hexanediamine, N1,N6-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymer with 2,4-dichloro-6-(4-morpholinyl)-1,3,5-triazine	617-335-9	82451-48-7	790	80480	yes	no	5 mg/kg	Average molecular weight not less than 2400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.	Details
(1,3:2,4) diparamethyldibenylidene sorbitol	617-241-8	81541-12-0	752	39890	yes	no			Details
lignosulphonic acid	617-129-9	8062-15-5	540	63940	yes	no	0.24 mg/kg	Only to be used as dispersant for plastics dispersions.	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
poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]	615-678-9	71878-19-8	740	81200	yes	yes	3 mg/kg		Details
bis(polyethyleneglycol)hydroxymethylphosphonate	614-830-1	68951-50-8	735	40120	yes	no	0.6 mg/kg		Details
methylsilsesquioxane	614-610-5	68554-70-1	730	66930	yes	no		Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.	Details
polyethylene waxes, oxidised	614-498-8	68441-17-8	811	80077	yes	no	60 mg/kg		Details
1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer	613-797-0	65447-77-0	716	60800	yes	no	30 mg/kg		Details
polydimethylsiloxane (Mw > 6800 Da)	613-156-5	63148-62-9	575	76721	yes	no		Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).	Details
diatomaceous earth	612-383-7	61790-53-2	707	46375	yes	no			Details
di(p-tolylidene)sorbitol	611-185-8	54686-97-4	752	39890	yes	no			Details
hydroxymethylcellulose	609-415-7	37353-59-6	686	61390	yes	no			Details
aluminum calcium oxide sulfate	609-389-7	37293-22-4	598	41600	yes	no			Details
nepheline syenite	609-369-8	37244-96-5	684	68125	yes	no			Details
polyester of 1,4-butanediol with caprolactone	608-670-1	31831-53-5	672	76845	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).	Details
polyester of 1,4-butanediol with caprolactone	608-670-1	31831-53-5	672	76845	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).	Details
polyglycerol ricinoleate	608-428-5	29894-35-7	668	80240	yes	no			Details
(butyl acrylate, methyl methacrylate, styrene) copolymer	608-050-0	27136-15-8	869	66763	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.	Details
maleic anhydride-styrene, copolymer, sodium salt	607-789-6	25736-61-2	642	64990	yes	no		The fraction with molecular weight below 1000 Da shall not exceed 0,05 % (w/w).	Details
polyglycerol	607-759-2	25618-55-7	1017		yes	no		To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.	Details
formaldehyde-1-naphthol, copolymer	607-708-4	25359-91-5	640	54930	yes	no	0.05 mg/kg		Details
(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer	607-698-1	25322-99-0	865	40619	yes	no		Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.	Details
huntite	606-340-1	19569-21-2	627	59760	yes	no			Details
poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-α-[N,N,N',N'-tetrabutyl-N''-(2,2,6,6-tetramethyl-4-piperidinyl)-N''-[6-(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-triamine]-ω-N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine]	606-265-4	192268-64-7	780	81220	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
alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated	604-520-4	146340-15-0	802	33105	yes	no	5 mg/kg		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
hydrotalcite	602-916-1	12304-65-3	604	60080	yes	no			Details
pyrophyllite	602-803-7	12269-78-2	603	83460	yes	no			Details
mica	601-648-2	12001-26-2	597	67120	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
acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled	500-231-1	68783-41-5	733	10599/93 10599/92A	no	no			Details
polyethyleneglycol ester of castor oil 1 - 6.5 moles ethoxylated	500-151-7	61791-12-6	708	77520	yes	no	42 mg/kg		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
polyethyleneglycol ester of hydrogenated castor oil 1 - 6.5 moles ethoxylated	500-147-5	61788-85-0	704	77600	yes	no			Details
poly(12-hydroxystearic acid) stearate	500-140-7	58128-22-6	875	80345	yes	yes	5 mg/kg		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
polyethyleneglycol sorbitan monostearate 1 - 6.5 moles ethoxylated	500-020-4	9005-67-8	571	79280	yes	no			Details
polyethyleneglycol sorbitan monooleate 1 - 6.5 moles ethoxylated	500-019-9	9005-65-6	569	79120	yes	no			Details
polyethyleneglycol sorbitan monolaurate 1 - 6.5 moles ethoxylated	500-018-3	9005-64-5	568	79040	yes	no			Details
N,N',N''-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamide	481-840-9	160535-46-6	870	95500	yes	no	5 mg/kg		Details
(triethanolamine-perchlorate, sodium salt) dimer	480-340-8	156157-97-0	1080		yes	no		Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.	Details
(triethanolamine-perchlorate, sodium salt) dimer	480-340-8	156157-97-0	1080		yes	no		Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.	Details

Showing 51 - 100 of 1,080 results.

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