plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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 28 March 2023. Database contains 1072 unique substances/entries.

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Showing 1 - 50 of 1,072 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate	-	-	1043		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene	-	-	859		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked	-	-	998		yes	no		Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.	Details
(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate	-	-	855	40560	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.	Details
(butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate	-	-	866	40620	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.	Details
(methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer	-	-	1016		yes	no		Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA. The final material shall be used at room temperature or below.	Details
(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer	-	-	979	79987	yes	no		Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.	Details
5,7-di-tert-butyl-3-(3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100 % w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20 % w/w)	-	-	26	46700	yes	no	5 mg/kg		Details
5-sulphoisophthalic acid, salts	-	-	823	24889	no	no	5 mg/kg		Details
9,10-dihydroxy stearic acid, oligomers	-	-	27	48960	yes	no	5 mg/kg		Details
acetylacetic acid, salts	-	-	7	30370	yes	no			Details
acetylated mono- and diglycerides of fatty acids	-	-	8	30401	yes	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
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
alkyl(C8-C22)sulphonic acids	-	-	16	34230	yes	no	6 mg/kg		Details
alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms	-	-	17	34281	yes	no			Details
alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines	-	-	15	34130	yes	yes	30 mg/kg		Details
aluminium fibers, flakes and powders	-	-	501	34480	yes	no			Details
carbonic acid, salts	-	-	21	42500	yes	no			Details
castor oil, mono- and diglycerides	-	-	22	43200	yes	no			Details
chlorides of choline esters of coconut oil fatty acids	-	-	23	43515	yes	no	0.9 mg/kg		Details
cis-1,2-cyclohexanedicarboxylic acid, salts	-	-	816	45704	yes	no	5 mg/kg		Details
cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts	-	-	817	38507	yes	no	5 mg/kg	Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %.	Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	186	14020	no	no	0.05 mg/kg		Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	103	18100 55920	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	112	64015	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	118	81882 23830	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	417	85680	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	357	13932	no	no	0.01 mg/kg	Only to be used as a co-monomer for the preparation of polymeric additive.	Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	147	10690	no	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	229	14140	no	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	139	44160 14680	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	311	51200 16480	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	114	55040	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	655	25450	no	no	0.05 mg/kg		Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	765	49485	yes	yes	1 mg/kg		Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	766	38879	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	770	51700	yes	no	0.05 mg/kg		Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	499	19965 65020	yes	no		In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.	Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	752	39890	yes	no			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	756	40020	yes	yes			Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	882	25872	no	no	0.05 mg/kg		Details

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FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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Last updated 28 March 2023. Database contains 1072 unique substances/entries.

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