EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 25 April 2024. Database contains 4821 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
reaction mass of isomers of: α-((dimethyl)biphenyl)-ω-hydroxypoly(oxyethylene)
EMULGATOR SWA; EMULVIN SWA
406-325-8
-
Acute Tox. 4
reaction mass of mono to tetra(lithium and/or sodium)3-amino-10-[4-(4-amino-3-sulfonatoanilino)-6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to tetra(lithium and/or sodium)3-amino-10-[4,6-bis(4-amino-3-sulfonatoanilino)-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to penta(lithium and/or sodium)10,10'-diamino-6,6',13,13'-tetrachloro-3,3'-[6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10-amino-6,6', 13,13'-tetrachloro-10'[4-(4-amino-3-sulfonatoanilino)-[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10,10'-diamino-6,6',3,3'[(2-sulfonato)-1,4-phenylenediiminobis[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate
430-200-7
-
Eye Dam. 1
reaction mass of n-octadecylaminodiethyl bis(hydrogen maleate); n-octadecylaminodiethyl hydrogen maleate hydrogenphthalate
ETHOXYLATED POLYESTER RESIN
405-960-8
-
Skin Sens. 1
reaction mass of O, O'-diisopropyl (pentathio)dithioformate and O, O'-diisopropyl (trithio)dithioformate and O, O'-diisopropyl (tetrathio)dithioformate
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
reaction mass of pentyl methylphosphinate and 2-methylbutyl methylphosphinate
MPA
402-090-0
87025-52-3
Skin Corr. 1B
reaction mass of trisodium 3-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate; trisodium 3-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate
436-890-6
-
Eye Dam. 1
reaction mass of α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene) and α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
reaction mass of: ((Z)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid; di-((E)-3,7-dimethyl-2,6-octadienyl) butandioate; di-((Z)-3,7-dimethyl-2,6-octadienyl) butandioate; (Z)-3,7-dimethyl-2,6-octadienyl butandioate; ((E)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid
MS6119
415-190-4
-
Skin Sens. 1
reaction mass of: (1'α, 3'α, 6'α)-2,2,3' ,7', 7'-pentamethylspiro(1,3-dioxane-5,2'-norcarane); (1'α, 3'β, 6'α)-2,2,3', 7', 7'-pentamethylspiro(1,3-dioxane-5,2'-norcarane)
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
reaction mass of: (1RS, 2RS,3SR, 6RS, 9SR)-9-methoxytricyclo[5.2.1.0(2,6)]decane-3-carbaldehyde; (1RS, 2RS, 3RS, 6RS, 8SR)-8-methoxytricyclo[5.2.1.0(2,6)]decane-3-carbaldehyde; (1RS, 2RS, 4SR, 6RS, 8SR)-8-methoxytricyclo[5.2.1.0(2,6)]decane-4-carbaldehyde
429-860-9
86803-90-9
Skin Sens. 1
reaction mass of: (1RS, 2SR,7SR, 8SR, E) 9 and 10-ethylidene-3-oxatricyclo[6.2.1.0(2,7)]undecan-4-one; (1RS, 2SR, 7SR, 8SR, Z)-10-ethylidene-3-oxatricyclo[6.2.1.0(2,7)]undecan-4-one; (1RS, 2SR, 7SR, 8SR, Z)-9-ethylidene-3-oxatricyclo[6.2.1.0(2,7)]undecan-4-one
434-290-9
249630-78-2
Acute Tox. 4
reaction mass of: (2R, 3R)-3-(2-ethoxyphenoxy)-2-hydroxy-3-phenylpropylammonium methanesulfonate; (2S, 3S)-3-(2-ethoxyphenoxy)-2-hydroxy-3-phenylpropylammonium methanesulfonate
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
reaction mass of: (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/ [tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)tetradec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/ [tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)tetradec-4-enoate
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: (3R)-[1S-(1α,2α, 6β-((2S)-2-methyl-1-oxo-butoxy)-8aγ)hexahydro-2,6-dimethyl-1-naphthalene]-3,5-dihydroxyheptanoic acid; inert biomass from Aspergillus terreus
LOVASTATIN FREE ACID
415-840-7
-
Skin Sens. 1
reaction mass of: 1,2-dimethylpropylidene dihydroperoxide; dimethyl 1,2-benzenedicarboxylate
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction mass of: 1,2-naphthoquinonediazide-5-sulfonylchloride (or sulfonic acid)monoester with 4,4'-(1-(4-(1-(4-hydroxyphenyl)-1-methylethyl)phenyl)ethylidene)bisphenol; 1,2-naphthoquinonediazide-5-sulfonylchloride(or sulfonicacid)diester with 4,4'-(1-(4-(1-(4-hydroxyphenyl)-1-methylethyl)phenyl)ethylidene)bisphenol; 1,2-naphthoquinonediazide-5-sulfonylchloride (or sulfonic acid)triester with 4,4'-(1-(4-(1-(4-hydroxyphenyl)-1-methylethyl)phenyl)ethylidene)bisphenol
433-640-8
-
Pyr. Sol. 1
reaction mass of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6 trione; reaction mass of oligomers of; 3,5-bis(3-aminomethylphenyl)1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5(1H,3H,5H)-triazine-2,4,6-trione
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
reaction mass of: 1,7-dimethyl-2-[(3-methylbicyclo[2.2.1]hept-2-yl)methyl]bicyclo[2.2.1]heptane; 2,3-dimethyl-2-[(3-methylbicyclo[2.2.1]hept-2-yl)methyl]bicyclo[2.2.1]heptane
427-040-5
-
Skin Corr. 1B
Reaction mass of: 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-tridecafluorooctyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-heptdecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-pentacosafluorotetradecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl)-12-(1''H,1''H,2''H,2''H-heptadecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl)-12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate
HFR-990
423-180-6
-
STOT RE 2
reaction mass of: 1-(1,1-dimethylpropyl)-4-ethoxy-cis-cyclohexane; 1-(1,1-dimethylpropyl)-4-ethoxy-trans-cyclohexane
426-530-6
-
Skin Irrit. 2
reaction mass of: 1-(4-isopropylphenyl)-1-phenylethane; 1-(3-isopropylphenyl)-1-phenylethane; 1-(2-isopropylphenyl)-1-phenylethane
430-690-2
52783-21-8
Skin Irrit. 2
reaction mass of: 1-deoxy-1-[methyl-(1-oxododecyl)amino]-D-glucitol; 1-deoxy-1-[methyl-(1-oxotetradecyl)amino]-D-glucitol (3:1)
GA1270; HOE S 4096
407-290-1
-
Eye Dam. 1
reaction mass of: 1-methyl-1-(3-(1-methylethyl)phenyl)ethyl-1-methyl-1-phenylethylperoxide,; 63 % by weight; 1-methyl-1-(4-(1-methylethyl)phenyl)ethyl-1-methyl-1-phenylethylperoxide, 31 % by weight
PEROXIMON S 168 TECHNICALLY PURE
410-840-3
71566-50-2
Org. Perox. C
reaction mass of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N, N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N, N-di(C18)alkylacetamide
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
reaction mass of: 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)]-3-oxo-butanamide; 2-[[3,3'-dichloro-4'-[[1[[(2,4-dimethylphenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'biphenyl]-4-yl]azo]-N-(2-methylphenyl)-3-oxo-butanamide; 2-[[3,3'-dichloro-4'-[[1[[(2,4-dimethylphenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'-biphenyl]-4-yl]azo]-N-(2-carboxylphenyl)-3-oxo-butanamide
434-330-5
-
Carc. 2; Skin Sens. 1
reaction mass of: 2,2'-[[(2-hydroxyethyl)imino]bis(methylene)bis[4-dodecylphenol]; formaldehyde, oligomer with 4-dodecyl phenol and 2-aminoethanol(n = 2); formaldehyde, oligomer with 4-dodecyl phenol and 2-aminoethanol(n = 3, 4 and higher)
Z-19
414-520-4
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: 2,2'-[[cis-1,2-cyclohexanediylbis(nitrilomethylidene)]bis[phenolate]](2-)N, N',O, O'-copper complex;2,2'-[[trans-1,2-cyclohexanediylbis(nitrilomethylidyne)]bis[phenolate]](2-)N, N',O, O'-copper complex
419-610-7
171866-24-3
STOT RE 2
reaction mass of: 2,2'-bis(tert-pentylperoxy)-p-diisopropylbenzene; 2,2'-bis(tert-pentylperoxy)-m-diisopropylbenzene
PEROXIMON 180
412-140-3
32144-25-5
Org. Perox. D
reaction mass of: 2,2'-dimethyl-2,2'-azobutanenitrile; 2-methylpentanenitrile-2-azo-2'-(2'-methylpropanenitrile); 2,2'-dimethyl-2,2'-azoheptanenitrile; 2-methylheptanenitrile-2-azo-2'-(2'-methylpropanenitrile); 2-methylheptanenitrile-2-azo-2'-(2'-methylbutanenitrile)
429-710-2
-
Self-react. D; Acute Tox. 4
reaction mass of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
reaction mass of: 2,2-dimethoxyethanal [this component is considered to be anhydrous in terms of identity, structure and composition. However, 2,2-dimethoxyethanal will exist in a hydrated form. 60 % anhydrous is equivalent to 70,4 % hydrate; water (Including free water and water in hydrated 2,2-dimethoxyethanal)]
HIGHLINK DM
421-890-0
51673-84-8
Skin Sens. 1
reaction mass of: 2,4,6-tri(butylcarbamoyl)-1,3,5-triazine; 2,4,6-tri(methylcarbamoyl)-1,3,5-triazine; [(2-butyl-4,6-dimethyl)tricarbamoyl]-1,3,5-triazine; [(2,4-dibutyl-6-methyl)tricarbamoyl]-1,3,5-triazine
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
reaction mass of: 2-(2-((oxo(phenyl)acetyl)oxy)ethoxy)ethyl oxo(phenyl)acetate; (2-(2-hydroxyethoxy)ethyl)oxo(phenyl)acetate
442-300-8
-
Skin Sens. 1
reaction mass of: 2-(3-(2,6-dichloro-4-nitrophenylazo)carbazol-9-yl)ethanol; 2-(2-(3-(2,6-dichloro-4-nitro-phenylazo)-carbazol-9-yl)ethoxy)ethanol; 3-(2,6-dichloro-4-nitrophenylazo)carbazol
429-590-1
-
Skin Sens. 1
reaction mass of: 2-(9-methyl-1,3,8,10-tetraoxo-2,3,9,10-tetrahydro-(1H,8H)-anthra[2,1,9-def: 6,5,10-d'e'f']diisoquinolin-2-ylethansulfonic acid; potassium 2-(9-methyl-1,3,8,10-tetraoxo-2,3,9,10-tetrahydro-(1H,8H)-anthra[2,1,9-def: 6,5,10-d'e'f']diisoquinolin-2-ylethansulfate
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
reaction mass of: 2-(hexylthio)ethylamine hydrochloride; sodium propionate
F1 MINERAL FLOTATION COLLECTOR (40% HTEA.HCL)
405-720-2
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
reaction mass of: 2-[N-ethyl-4-[(5,6-dichlorobenzothiazol-2-yl)azo]-m-toludino]ethyl acetate; 2-[N-ethyl-4-[(6,7-dichlorobenzothiazol-2-yl)azo]-m-toludino]ethyl acetate (1:1)
RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
reaction mass of: 2-chloro-5-sec-tetradecylhydroquinones where sec-tetradecyl = 1-methyltridecyl; 1-ethyldodecyl; 1-propylundecyl; 1-butyldecyl; 1-pentylnonyl; 1-hexyloctyl
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
reaction mass of: 2-ethylhexyl 2,3,4,5-tetrabromobenzoate; bis(2-ethylhexyl) 3,4,5,6-tetrabromophthalate
428-050-2
-
Skin Sens. 1
reaction mass of: 2-ethylhexyl linolenate, linoleate and oleate; 2-ethylhexyl epoxyoleate; 2-ethylhexyl diepoxylinoleate; 2-ethylhexyl triepoxylinolenate
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
reaction mass of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside
SPE 93279
414-420-0
-
Eye Dam. 1
reaction mass of: 2-hydroxy-3-(methacryloyloxy)propyl (2-benzoyl)benzoate; 1-hydroxymethyl-2-(methacryloyloxy)ethyl (2-benzoyl)benzoate; x-hydroxy-y-(methacryloyloxy)propyl(or -ethyl) (2-benzoyl)benzoate
419-000-0
-
Skin Sens. 1
reaction mass of: 2-methoxy-4-(tetrahydro-4-methylene-2H-pyran-2-yl)-phenol; 4-(3,6-dihydro-4-methyl-2H-pyran-2-yl)-2-methoxyphenol
EUGEWHITE
412-020-0
-
Skin Sens. 1
reaction mass of: 2-methyl-1-(6-methylbicyclo[2.2.1]hept-5-en-2-yl)pent-1-en-3-ol; 2-methyl-1-(1-methylbicyclo[2.2.1]hept-5-en-2-yl)-pent-1-en-3-ol; 2-methyl-1-(5-methylbicyclo[2.2.1]hept-5-en-2-yl)pent-1-en-3-ol
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
reaction mass of: 2-methylnonanedioic acid; 2,4-dimethyl-4-methoxycarbonylundecanedioic acid; 2,4,6-trimethyl-4,6-dimethoxycarbonyltridecanedioic acid; 8,9-dimethyl-8,9-dimethoxycarbonylhexadecanedioic acid
MMA-10R
423-670-1
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: 2-methylsulfanyl-4,6-bis-(2-hydroxy-4-methoxy-phenyl)-1,3,5-triazine; 2-(4,6-bis-methylsulfanyl-1,3,5-triazin-2-yl)-5-methoxy-phenol
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
reaction mass of: 2-{3,6-bis-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl[}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,3-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,4-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,4-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,5-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2,4-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,4-dimethylphenyl)-methylamino]-6-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %)
442-800-6
-
Skin Irrit. 2
Reaction mass of: 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanesulfonic acid; ammonium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanesulfonate
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
Reaction mass of: 3,7,11-trimethyl-cis-6,10-dodecadienal; 3,7,11-trimethyl-trans-6,10-dodecadienal
425-910-9
32480-08-3
Skin Irrit. 2
reaction mass of: 3-(N-(3-dimethylaminopropyl)-(C4-8)perfluoroalkylsulfonamido)propionic acid; N-[dimethyl-3-(C4-8-perfluoroalkylsulfonamido)propylammonium propionate; 3-(N-(3-dimethyl-propylammonium)-(C4-8)perfluoroalkylsulfonamido)propionic acid propionate
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
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