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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 19 April 2024. Database contains 1080 unique substances/entries.

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Showing 101 - 150 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
2,2'-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate	286-344-4	85209-91-2	749	66360	yes	yes	5 mg/kg		Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	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.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no	6 mg/kg	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.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	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.	Details
phthalic anhydride	201-607-5	85-44-9	158	23380 76320	yes	no			Details
bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH)	283-829-2	84731-70-4	1079		yes	no	0.05 mg/kg	Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.	Details
N-(2-aminoethyl)-β-alanine, sodium salt	282-811-1	84434-12-8	748	12765	no	no	0.05 mg/kg		Details
di-n-dodecyltin bis(isooctyl mercaptoacetate)	281-837-0	84030-61-5	747	47600	yes	yes			Details
2,6-naphthalenedicarboxylic acid, dimethyl ester	212-661-4	840-65-3	373	22390	no	no	0.05 mg/kg		Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no	0.12 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	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
hexamethylene diisocyanate	212-485-8	822-06-0	372	18640	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
acrylic acid, monoester with ethyleneglycol	212-454-9	818-61-1	371	11830 11510	no	no			Details
(1,3:2,4) diparamethyldibenylidene sorbitol	617-241-8	81541-12-0	752	39890	yes	no			Details
bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite ADK STAB PEP-36	410-290-4	80693-00-1	746	38810	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	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
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
2,4,4'-trifluorobenzophenone	813-638-7	80512-44-3	1061		no	no		Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.	Details
rosin, ester with glycerol	232-482-5	8050-31-5	538	84000	yes	no			Details
rosin, ester with pentaerythritol	232-479-9	8050-26-8	537	84080	yes	no			Details
rosin, hydrogenated, ester with methanol	232-476-2	8050-15-5	536	84320	yes	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
2,2',2'-nitrilo(triethyl tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite)	279-459-6	80410-33-9	745	68145	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	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
polyphosphoric acids	232-417-0	8017-16-1	534	80720	yes	no			Details
carnauba wax The wax derived from Copernicia cerifera, Palmae.	232-399-4	8015-86-9	533	42720	yes	no			Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	60 mg/kg		Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no			Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	30 mg/kg	In the case of PVC gaskets used to seal glass jars containing 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, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.	Details
beeswax The wax obtained from the honeycomb of the bee. It consists primarily of myricyl palmitate, cerotic acid and esters and some high-carbon paraffins.	232-383-7	8012-89-3	531	36880	yes	no			Details
candelilla wax The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.	232-347-0	8006-44-8	530	41760	yes	no			Details
montan wax Wax obtained by extraction of lignite.	232-313-5	8002-53-7	529	67850	yes	no			Details
lecithin The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.	232-307-2	8002-43-5	528	63760	yes	no			Details
castor oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic. (Ricinus communis, Euphorbiaceae).	232-293-8	8001-79-4	527	42880 14411	yes	no			Details
ceresin A complex combination of hydrocarbons produced by the purification of ozocerite with sulfuric acid and filtration through bone black to form waxy cakes.	232-290-1	8001-75-0	526	43440	yes	no			Details
japan wax	-	8001-39-6	525	62640	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
methacrylic acid, methyl ester	201-297-1	80-62-6	156	21130	no	no			Details
α-pinene	201-291-9	80-56-8	155	23470	no	no			Details
4,4'-dihydroxydiphenyl sulphone	201-250-5	80-09-1	154	13617 16090	no	no	0.05 mg/kg		Details
4,4'-diaminodiphenyl sulphone	201-248-4	80-08-0	153	15267	no	no	5 mg/kg		Details
4,4'-dichlorodiphenyl sulphone	201-247-9	80-07-9	152	15610	no	no	0.05 mg/kg		Details
2,2-bis(4-hydroxyphenyl)propane	201-245-8	80-05-7	151	13480 13607	no	no	0.05 mg/kg	Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union]. Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].	Details
bis(4-ethylbenzylidene)sorbitol NC-4	406-176-9	79072-96-1	743	38950	yes	no			Details
methacrylic acid	201-204-4	79-41-4	150	20020	no	no			Details
methacrylamide	201-202-3	79-39-0	149	19990	no	no	0.01 mg/kg		Details
chlorotrifluoroethylene	201-201-8	79-38-9	148	14650	no	no	0.01 mg/kg		Details
glycolic acid	201-180-5	79-14-1	794	18117	no	no		Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.	Details

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