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

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Showing 301 - 400 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids	-	-	924	94987	yes	no	0.05 mg/kg	Only for use in PET in contact with all types of foods other than fatty, high- alcoholic and dairy products.	Details
waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity	-	-	93	95858	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. Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).	Details
waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity	-	-	94	95859	yes	no		Average molecular weight not less than 500 Da. Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)	Details
white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks	-	-	95	95883	yes	no		Average molecular weight not less than 480 Da. Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)	Details
(1,3-phenylenedioxy)diacetic acid	203-027-8	102-39-6	202	23070	no	no	0.05 mg/kg		Details
(2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)	264-144-8	63438-80-2	711	42000	yes	yes	30 mg/kg		Details
(perfluorobutyl)ethylene	243-053-7	19430-93-4	973	22931	no	no		Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.	Details
1,1,1-trimethylolpropane	201-074-9	77-99-6	141	94960 25600 13380	yes	no	6 mg/kg		Details
1,1,1-trimethylolpropane trimethacrylate	221-950-4	3290-92-4	463	25840	no	no	0.05 mg/kg		Details
1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane	217-420-7	1843-03-4	430	95600	yes	yes	5 mg/kg		Details
1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane	252-816-3	35958-30-6	679	39060	yes	yes	5 mg/kg		Details
1,1-difluoroethane	200-866-1	75-37-6	131	48460	yes	no			Details
1,10-decanediamine	211-471-9	646-25-3	863	15260	no	no	0.05 mg/kg	Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.	Details
1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich	271-090-9	68515-48-0	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
1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich	271-090-9	68515-48-0	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
1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich	271-091-4	68515-49-1	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
1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich	271-091-4	68515-49-1	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
1,2-benziso-thiazol-3(2H)-one 1,1-dioxide, sodium salt	204-886-1	128-44-9	902		yes	no		The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (OJ L 83, 22.3.2012, p. 1).	Details
1,2-dihydroxybenzene	204-427-5	120-80-9	289	24051 15880	no	no	6 mg/kg		Details
1,2-propanediol	200-338-0	57-55-6	109	23740 81840	yes	no			Details
1,2-propyleneglycol dilaurate	245-217-3	22788-19-8	630	82240	yes	no			Details
1,2-propyleneglycol dioleate	203-315-3	105-62-4	213	82400	yes	no			Details
1,2-propyleneglycol dipalmitate	251-581-4	33587-20-1	677	82560	yes	no			Details
1,2-propyleneglycol distearate	228-229-3	6182-11-2	491	82720	yes	no			Details
1,2-propyleneglycol monolaurate	248-315-4	27194-74-7	659	82800	yes	no			Details
1,2-propyleneglycol monooleate	215-549-3	1330-80-9	408	82960	yes	no			Details
1,2-propyleneglycol monopalmitate	249-369-1	29013-28-3	665	83120	yes	no			Details
1,2-propyleneglycol monostearate	215-354-3	1323-39-3	406	83300	yes	no			Details
1,3,5-benzenetricarboxylic acid trichloride	224-594-8	4422-95-1	481	13060	no	no	0.05 mg/kg	SML expressed as 1,3,5-benzenetricarboxylic acid.	Details
1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene	216-971-0	1709-70-2	428	95200	yes	no			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
1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione	254-996-9	40601-76-1	689	95280	yes	yes	6 mg/kg		Details
1,3-benzenedimethanamine	216-032-5	1477-55-0	421	13000	no	no			Details
1,3-bis(2-hydroxyethoxy)benzene	203-028-3	102-40-9	203	13323	no	no	0.05 mg/kg		Details
1,3-bis(isocyanatomethyl)benzene	222-852-4	3634-83-1	988		no	no		SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine. To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.	Details
1,3-butanediol	203-529-7	107-88-0	228	13690	no	no			Details
1,3-dihydroxybenzene	203-585-2	108-46-3	237	24072 15910	no	no	2.4 mg/kg		Details
1,3-dioxolane	211-463-5	646-06-0	363	16450	no	no	5 mg/kg		Details
1,3-phenylenediamine	203-584-7	108-45-2	236	23050	no	no	0.01 mg/kg		Details
1,3-propanediol	207-997-3	504-63-2	343	23770	no	no	0.05 mg/kg		Details
1,4-bis(hydroxymethyl)cyclohexane	203-268-9	105-08-8	210	13390 14880	no	no			Details
1,4-butanediol	203-786-5	110-63-4	254	40580 13720	yes	no			Details
1,4-butanediol bis(2,3-epoxypropyl)ether	219-371-7	2425-79-8	442	13780	no	no	0.01 mg/kg	Residual content = 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no			Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no	0.05 mg/kg		Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no			Details
1,4-cyclohexanedicarboxylic acid	214-068-6	1076-97-7	806	14876	no	no	5 mg/kg	Only to be used for manufacture of polyesters.	Details
1,4-diaminobutane	203-782-3	110-60-1	253	15250	no	no			Details
1,4-dichlorobenzene	203-400-5	106-46-7	217	15565	no	no	12 mg/kg		Details
1,4-dihydroxybenzene	204-617-8	123-31-9	295	48620 15940 18867	yes	no	0.6 mg/kg		Details
1,4:3,6-dianhydrosorbitol	211-492-3	652-67-5	364	15404	no	no	5 mg/kg	Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.	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
1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)	245-442-7	23128-74-7	631	59120	yes	yes	45 mg/kg		Details
1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)	252-346-9	35074-77-2	678	59200	yes	yes	6 mg/kg		Details
1,6-hexanediol	211-074-0	629-11-8	361	18700	no	no	0.05 mg/kg		Details
1,7-octadiene	223-054-9	3710-30-3	1034		no	no	0.05 mg/kg	Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.	Details
1,9-decadiene	216-711-6	1647-16-1	424	15070	no	no	0.05 mg/kg		Details
1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride	223-805-0	4080-31-3	474	43600	yes	no	0.3 mg/kg		Details
1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane	220-666-8	2855-13-2	454	12670	no	no	6 mg/kg		Details
1-butanol	200-751-6	71-36-3	123	13840	no	no			Details
1-butene	203-449-2	106-98-9	222	13870	no	no			Details
1-decanol	203-956-9	112-30-1	267	15100	no	no			Details
1-decene	212-819-2	872-05-9	375	15130	no	no	0.05 mg/kg		Details
1-dodecene	203-968-4	112-41-4	268	16704	no	no	0.05 mg/kg		Details
1-hexadecanol	253-149-0	36653-82-4	681	18310	no	no			Details
1-hexene	209-753-1	592-41-6	356	18820	no	no	3 mg/kg		Details
1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane	223-861-6	4098-71-9	475	19110	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
1-nonanol	205-583-7	143-08-8	331	22480	no	no			Details
1-octanol	203-917-6	111-87-5	265	22600	no	no			Details
1-octene	203-893-7	111-66-0	264	22660	no	no	15 mg/kg		Details
1-pentanol	200-752-1	71-41-0	124	22870	no	no			Details
1-pentene	203-694-5	109-67-1	245	22900	no	no	5 mg/kg		Details
1-propanol	200-746-9	71-23-8	122	23800	no	no			Details
1-tetradecene	214-306-9	1120-36-1	388	25080	no	no	0.05 mg/kg		Details
1-vinylimidazole	214-012-0	1072-63-5	387	26155	no	no	0.05 mg/kg		Details
11-aminoundecanoic acid	219-417-6	2432-99-7	443	12788	no	no	5 mg/kg		Details
12-aminododecanoic acid	211-754-7	693-57-2	369	12761	no	no	0.05 mg/kg		Details
12-hydroxystearic acid	203-366-1	106-14-9	214	61840	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
2,2'-dihydroxy-4-methoxybenzophenone	205-026-8	131-53-3	317	48880	yes	yes			Details
2,2'-dihydroxy-5,5'-dichlorodiphenylmethane	202-567-1	97-23-4	179	48800	yes	yes	12 mg/kg		Details
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
2,2'-methylene bis(4-ethyl-6-tert-butylphenol)	201-814-0	88-24-4	163	66400	yes	yes			Details
2,2'-methylene bis(4-methyl-6-tert-butylphenol)	204-327-1	119-47-1	285	66480	yes	yes			Details
2,2'-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)	201-044-5	77-62-3	137	66580	yes	yes			Details
2,2'-methylenebis(4-methyl-6-cyclohexylphenol)	223-773-8	4066-02-8	472	66560	yes	yes			Details
2,2'-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	274-572-7	70331-94-1	739	70000	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
2,2,4-trimethyl-1,3-pentanediol diisobutyrate	229-934-9	6846-50-0	497	95020	yes	no	5 mg/kg	Only to be used in single-use gloves.	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
2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether	216-823-5	1675-54-3	426	13610 13510	no	no		In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].	Details
2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride)	253-781-7	38103-06-9	687	13614 13530	no	no	0.05 mg/kg		Details
2,2-bis(hydroxymethyl)propionic acid	225-306-3	4767-03-7	484	13395	no	no	0.05 mg/kg		Details
2,2-dimethyl-1,3-propanediol	204-781-0	126-30-7	310	16390 22437	no	no	0.05 mg/kg		Details
2,3,6-trimethylphenol	219-330-3	2416-94-6	882	25872	no	no	0.05 mg/kg		Details
2,4,6-triamino-1,3,5-triazine	203-615-4	108-78-1	239	25420 19975 93720	yes	no	2.5 mg/kg		Details
2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine	213-590-1	991-84-4	384	40000	yes	yes	30 mg/kg		Details
2,4-diamino-6-hydroxypyrimidine	200-254-4	56-06-4	864	46330	yes	no	5 mg/kg	Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.	Details
2,4-diamino-6-phenyl-1,3,5-triazine	202-095-6	91-76-9	168	13075 15310	no	no	5 mg/kg		Details
2,4-dihydroxybenzophenone	205-029-4	131-56-6	318	48640	yes	no			Details

Showing 301 - 400 of 1,080 results.

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