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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 601 - 650 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
albumin	-	266309-43-7	1	12310	no	no			Details
aluminium hydroxide	244-492-7	21645-51-2	629	34560	yes	no			Details
benzoic acid, propyl ester	219-020-8	2315-68-6	441	38160	yes	no			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
bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	247-952-5	26741-53-7	652	38820	yes	yes	0.6 mg/kg		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
caprolactam, sodium salt	218-336-3	2123-24-2	435	14230	no	no			Details
cyclic oligomers of (butylene terephthalate)	-	263244-54-8	885	45676	yes	no		Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.	Details
di-n-octyltin bis(isooctyl mercaptoacetate)	247-666-0	26401-97-8	646	50480	yes	no			Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
dibutylthiostannoic acid polymer	-	26427-07-6	649	47210	yes	no		Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).	Details
diisodecyl phthalate	247-977-1	26761-40-0	729	75105	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
diisodecyl phthalate	247-977-1	26761-40-0	729	75105	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
diisononyl phthalate	249-079-5	28553-12-0	728	75100	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085.	Details
diisononyl phthalate	249-079-5	28553-12-0	728	75100	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085.	Details
dimethyltin bis(isooctyl mercaptoacetate)	247-862-6	26636-01-1	650	49600	yes	no			Details
dioctadecyl disulphide	219-702-5	2500-88-1	449	49840	yes	yes	0.05 mg/kg		Details
dipropyleneglycol	246-770-3	25265-71-8	257	16660 13550 51760	yes	no			Details
dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene	-	287916-86-3	871		yes	no		Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.	Details
dodecylbenzenesulphonic acid	248-289-4	27176-87-0	658	52000	yes	no	30 mg/kg		Details
ethylene-vinyl acetate copolymer wax	429-840-1	24937-78-8	969		yes	no		Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.	Details
formaldehyde-1-naphthol, copolymer	607-708-4	25359-91-5	640	54930	yes	no	0.05 mg/kg		Details
gadoleic acid	-	29204-02-2	667	55190	yes	no			Details
glycerol monohexanoate	-	26402-23-3	647	56720	yes	no			Details
glycerol monooctanoate	247-668-1	26402-26-6	648	56880	yes	no			Details
lauric acid, vinyl ester	218-414-7	2146-71-6	436	19480	no	no			Details
linolenic acid	217-792-0	28290-79-1	663	64150	yes	no			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
methacrylic acid, 2-(dimethylamino)-ethyl ester	220-688-8	2867-47-2	455	20530	no	no	0.01 mg/kg		Details
methacrylic acid, benzyl ester	219-674-4	2495-37-6	447	20080	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
methacrylic acid, phenyl ester	218-542-3	2177-70-0	439	21280	no	no			Details
methacrylic acid, propyl ester	218-639-0	2210-28-8	440	21340	no	no			Details
methacrylic acid, sec-butyl ester	221-073-7	2998-18-7	457	20140	no	no			Details
mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane	247-063-2	25513-64-8	641	22331	no	no	0.05 mg/kg		Details
mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)	248-227-6	27107-89-7	657	67680	yes	no			Details
mono-n-octyltin tris(isooctyl mercaptoacetate)	247-665-5	26401-86-5	645	67760	yes	no			Details
neodecanoic acid, salts	248-093-9	26896-20-8	819	68110	yes	no	0.05 mg/kg	Not to be used in polymers contacting fatty foods. Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. SML expressed as neodecanoic acid.	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
pentaerythritol dioleate	246-665-2	25151-96-6	637	71635	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.	Details
polyethyleneglycol 1 - 4.5 moles ethoxylated	500-038-2	25322-68-3	638	23590 76960	yes	no			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
polyglycerol ricinoleate	608-428-5	29894-35-7	668	80240	yes	no			Details
polypropyleneglycol 1 - 4.5 moles propoxylated	500-039-8	25322-69-4	639	23651 80800	yes	no			Details
pyrophosphoric acid	219-574-0	2466-09-3	445	83440	yes	no			Details
sebacic anhydride	219-882-5	2561-88-8	450	24430	no	no			Details
sorbitan dioleate	249-448-0	29116-98-1	666	87280	yes	no			Details
sorbitan monopalmitate	247-568-8	26266-57-9	643	87760	yes	no			Details
sorbitan trioleate	247-569-3	26266-58-0	644	88080	yes	no			Details
sorbitan tristearate	247-891-4	26658-19-5	651	88240	yes	no			Details

Showing 601 - 650 of 1,080 results.

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