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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 01 maj 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)
1,1,1-trimethylolpropane trimethacrylate	221-950-4	3290-92-4	463	25840	no	no	0.05 mg/kg		Details
N,N'-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide	251-156-3	32687-78-8	675	38800	yes	yes	15 mg/kg		Details
dibenzylidene sorbitol	251-136-4	32647-67-9	674	46480	yes	no			Details
ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]	251-073-2	32509-66-3	673	53670	yes	yes	6 mg/kg		Details
furan-2,5-dicarboxylic acid	221-800-8	3238-40-2	1031		no	no	5 mg/kg	Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).	Details
mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate	915-277-1	32052-51-0	4	22332	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
N-vinyl-N-methylacetamide	221-698-5	3195-78-6	462	26170	no	no	0.02 mg/kg		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
1,5-naphthalene diisocyanate	221-641-4	3173-72-6	461	22420	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
cyclohexyl isocyanate	221-639-3	3173-53-3	460	14950	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
phosphorous acid, tris(2,4-di-tert-butylphenyl)ester	250-709-6	31570-04-4	671	74240	yes	no			Details
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester	221-532-1	3135-18-0	459	46870	yes	no			Details
glycerol monolaurate diacetate	250-379-3	30899-62-8	670	56800	yes	no			Details
glass microballs	919-828-7	308066-94-6	39	55600	yes	no			Details
behenamide	221-304-1	3061-75-4	458	36960	yes	no			Details
glycerol monobehenate	250-097-0	30233-64-8	669	56610	yes	no			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
oleamide	206-103-9	301-02-0	335	68960	yes	no			Details
methacrylic acid, sec-butyl ester	221-073-7	2998-18-7	457	20140	no	no			Details
acrylic acid, sec-butyl ester	221-072-1	2998-08-5	456	10810	no	no			Details
polyglycerol ricinoleate	608-428-5	29894-35-7	668	80240	yes	no			Details
gadoleic acid	-	29204-02-2	667	55190	yes	no			Details
sorbitan dioleate	249-448-0	29116-98-1	666	87280	yes	no			Details
1,2-propyleneglycol monopalmitate	249-369-1	29013-28-3	665	83120	yes	no			Details
trimethylolpropane trimethacrylate-methyl methacrylate copolymer	927-697-2	28931-67-1	664	95000	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
methacrylic acid, 2-(dimethylamino)-ethyl ester	220-688-8	2867-47-2	455	20530	no	no	0.01 mg/kg		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
1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane	220-666-8	2855-13-2	454	12670	no	no	6 mg/kg		Details
linolenic acid	217-792-0	28290-79-1	663	64150	yes	no			Details
1,1,1-tris(4-hydroxyphenol)ethane THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE	405-800-7	27955-94-8	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
vinyltrimethoxysilane	220-449-8	2768-02-7	453	26320	no	no	0.05 mg/kg		Details
1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione	248-597-9	27676-62-6	661	95360	yes	yes	5 mg/kg		Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine	412-440-4	2725-22-6	452	38885	yes	no	5 mg/kg		Details
1,2-propyleneglycol monolaurate	248-315-4	27194-74-7	659	82800	yes	no			Details
dodecylbenzenesulphonic acid	248-289-4	27176-87-0	658	52000	yes	no	30 mg/kg		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
mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)	248-227-6	27107-89-7	657	67680	yes	no			Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	no	0.05 mg/kg		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
sorbitol monostearate	248-027-9	26836-47-5	654	88600	yes	no			Details
2-methyl-4-isothiazolin-3-one	220-239-6	2682-20-4	451	66755	yes	no	0.5 mg/kg	Only to be used in aqueous polymer dispersions and emulsions.	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
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
bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	247-952-5	26741-53-7	652	38820	yes	yes	0.6 mg/kg		Details

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