EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 25 april 2024. Database contains 4753 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: N-(3-dimethylamino-4-methyl-phenyl)-benzamide; N-(3-dimethylamino-2-methyl-phenyl)-benzamide; N-(3-dimethylamino-3-methyl-phenyl)-benzamide
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
-
STOT RE 2
reaction mass of: N-(3-(trimethoxysilyl)propyl)ethylenediamine; N-benzyl-N-(3-(trimethoxysilyl)propyl)ethylenediamine; N-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine; N, N'-bis-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine; N, N,N'-tris-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine; N, N-bis-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine
414-340-6
-
Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: N, N'-Ethane-1,2-diylbis(decanamide); 12-Hydroxy-N-[2-[1-oxydecyl)amino]ethyl]octadecanamide; N, N'-Ethane-1,2-diylbis(12hydroxyoctadecanamide)
430-050-2
-
Skin Sens. 1
reaction mass of: monosodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; disodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; trisodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; tetrasodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1
reaction mass of: mono-and di-glycerols of canola oil; canola oil acid amide of branched 1,3-propanediamine, N-[3-(tridecyloxy)-propyl]; N, N-diorgano dithiocarbamate molybdenum complex
434-240-6
-
Skin Sens. 1
reaction mass of: methyl {[5-acetylamino-4-(2-chloro-4-nitrophenylazo)phenyl]methoxycarbonylmethylamino}acetate; methyl {[5-acetylamino-4-(2-chloro-4-nitrophenylazo)phenyl]ethoxycarbonylmethylamino}acetate
424-290-7
188070-47-5
Skin Sens. 1
reaction mass of: methyl 3-((1E)-2-methylprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; methyl 3-((1Z)-2-methylprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate (20:80)
435-450-0
5460-63-9
Skin Sens. 1
reaction mass of: isobutyl hydrogen 2-(α-2,4,6-trimethylnon-2-enyl)succinate; isobutyl hydrogen 2-(β-2,4,6-trimetyhylnon-2-enyl)succinate
MCP 938
410-720-0
141847-13-4
Eye Dam. 1
reaction mass of: hydroxyaluminium bis[2-hydroxy-3,5-di-tert-butylbenzoate]; 3,5-di-tert-butyl-salicylic acid
BONTRON E-88
406-890-0
130296-87-6
Acute Tox. 4
reaction mass of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
CYANEX (R) EXTRACTANT; CYANEX 923 EXTRACTANT
403-470-9
-
Skin Corr. 1B
reaction mass of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
FRUITATE
407-520-0
80657-64-3
Skin Irrit. 2
reaction mass of: ethyl (2R, 3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S, 3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
427-090-8
116044-44-1
Skin Sens. 1
reaction mass of: endo-2-methyl-exo-3-methyl-exo-2-[(exo-3-methylbicyclo[2.2.1]hept-exo-2-yl)methyl]bicyclo[2.2.1]heptane; exo-2-methyl-exo-3-methyl-endo-2-[(endo-3-methylbicyclo[2.2.1]hept-exo-2-yl)methyl]bicyclo[2.2.1]heptane
434-420-4
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: dodecyl N-(2,2,6,6-tetramethylpiperidin-4-yl)-β-alaninate; tetradecyl N-(2,2,6,6-tetramethylpiperidin-4-yl)-β-alaninate
VP SANDUVOR 3052 LIQUIDE
405-670-1
119530-69-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
reaction mass of: dodecanoic acid; poly(1-7)lactate esters of dodecanoic acid
PRICARE
411-860-5
-
Skin Sens. 1
reaction mass of: dodecanoic acid (35-40 %); poly(1-7)lactate esters of dodecanoic acid (60-65 %)
PRIAZUL LAUROYL LACTYLATE; PRICARE LAURYL LACTYLATE (1:1.5)
412-590-0
58856-63-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: disodium hexyldiphenyl ether disulphonate; disodium dihexyldiphenyl ether disulphonate
DOWFAX (R) DRY HYDROTROPE POWDER
429-650-7
147732-60-3
Eye Irrit. 2
reaction mass of: disodium 7-(2,4-difluoropyrimidin-6-ylamino)-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)naphthalene-2-sulfonate; disodium; 7-(4,6-difluoropyrimidin-2-ylamino)-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)naphthalene-2-sulfonate
426-840-1
-
Eye Dam. 1
reaction mass of: disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(ethensulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex; disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(2-hydroxyethylsulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex
PACIFIED REACTIVE BLACK 31
423-940-7
85585-91-7
Eye Dam. 1
reaction mass of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate; trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate
DYE K
402-660-9
-
Repr. 1B
reaction mass of: disodium (6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxidophenylazo)-1-naphtholato)(1-(5-chloro-2-oxidophenylazo)-2-naphtholato)chromate(1-); trisodium bis(5-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxidophenylazo)-1-naphtholato)chromate(1-)
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
reaction mass of: dimethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate; diethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate; methyl ethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
reaction mass of: diester of 4,4'-methylenebis[2-(2-hydroxy-5-methylbenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulfonic acid (1:2); triester of 4,4'-methylenebis[2-(2-hydroxy-5-methylbenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulfonic acid (1:3)
427-140-9
-
Carc. 2
reaction mass of: dicalcium (bis(2-hydroxy-5-tetra-propenylphenylmethyl)methylamine)dihydroxide; tri-calcium (tris(2-hydroxy-5-tetra-propenylphenylmethyl)methylamine)tri-hydroxide; poly[calcium ((2-hydroxy-5-tetra-propenyl-phenylmethyl)methylamine)hydroxide]
OLOA 224 (OIL FREE)
420-470-4
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
reaction mass of: diastereoisomers of 1-(1-hydroxyethyl)-4-(1-methylethyl)cyclohexane
MUGETANOL
407-640-3
63767-86-2
Eye Irrit. 2; Skin Irrit. 2
reaction mass of: di-(1-octane-N, N,N-trimethylammonium) octylphosphate; 1-octane-N, N,N-trimethylammonium di-octylphosphate; 1-octane-N, N,N-trimethylammonium octylphosphate
NEWLON AM-92I
407-490-9
-
Acute Tox. 4; Skin Corr. 1B
reaction mass of: cis-9-octadecenedioic acid; cis-9-cis-12-octadecadienedioic acid; hexadecanedioic acid; octadecanedioic acid
422-260-8
20701-68-2
Eye Dam. 1
reaction mass of: cis-2-isobutyl-5-methyl 1,3-dioxane; trans-2-isobutyl-5-methyl 1,3-dioxane
CAMONAL
426-130-1
166301-21-9
Skin Irrit. 2
reaction mass of: cis-(5-ammonium-1,3,3-trimethyl)-cyclohexanemethylammonium phosphate (1:1); trans-(5-ammonium-1,3,3-trimethyl)-cyclohexanemethylammonium phosphate (1:1)
VESTAGON EP S 270
411-830-1
114765-88-7
Eye Dam. 1; Skin Sens. 1
reaction mass of: carbonato-bis-N-ethyl-2-isopropyl-1,3-oxazolidine; methyl carbonato-N-ethyl-2-isopropyl-1,3-oxazolidine; 2-isopropyl-N-hydroxyethyl 1,3-oxazolidine
429-990-6
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: calcium bis(C10-14 branched alkyl salicylate); calcium bis(C18-30-alkyl salicylate); calcium C10-14 branched alkylsalicylato-C18-30-alkyl salicylate; calcium bis (C10-14 branched alkyl phenolate); calcium bis (C18-30-alkyl phenolate); calcium C10-14 branched alkylphenolato-C18-30-alkyl phenolate; C10-14 branched alkyl phenol; C18-30-alkyl phenol
SP 7077
430-180-1
-
Skin Irrit. 2
reaction mass of: Ca salicylates (branched C10-14 and C18-30 alkylated); Ca phenates (branched C10-14 and C18-30 alkylated); Ca sulfurised phenates(branched C10-14 and C18-30 alkylated)
SP 7053
415-930-6
-
Repr. 2; Skin Sens. 1
reaction mass of: butan-2-one oxime; syn-O,O'-di(butan-2-one oxime)diethoxysilane
DOW CORNING (R) 4-2920 INTERMEDIATE
406-930-7
96-29-7
STOT RE 1; Skin Sens. 1
reaction mass of: branched icosane; branched docosane; branched tetracosane
417-050-8
151006-58-5
Acute Tox. 4
reaction mass of: bis[(2-ethyl-1-oxohexyl)oxy]dioctyl stannane; bis[((2-ethyl-1-oxohexyl)oxy)dioctylstannyl]oxide; bis(1-phenyl-1,3-decanedionyl)dioctyl stannane; ((2-ethyl-1-oxohexyl)oxy)-(1-phenyl-1,3-decanedionyl)dioctyl stannane
422-920-5
-
STOT RE 2
reaction mass of: bis(tris(2-(2-hydroxy(1-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate; bis(tris(2-(2-hydroxy(2-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
reaction mass of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene (1:2:1)
MDI
406-550-1
-
Skin Sens. 1
reaction mass of: bis(isotridecylammonium)mono(di-(4-methylpent-2-yloxy)thiophosphorothionylisopropyl)phosphate; isotridecylammonium bis(di-(4-methylpent-2-yloxy)thiophosphorothionylisopropyl)phosphate
MCP 455
406-240-6
-
Flam. Liq. 3; Skin Corr. 1B
reaction mass of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
reaction mass of: ammonium-1,2-bis(hexyloxycarbonyl)ethanesulfonate; ammonium-1-hexyloxycarbonyl-2-octyloxycarbonylethanesulfonate; ammonium-2-hexyloxycarbonyl-1-octyloxycarbonylethanesulfonate
AMMONIUM DIAS
407-320-3
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: [1-(methoxymethyl)-2-(C12-alkoxy)-ethoxy]acetic acid; [1-(methoxymethyl)-2-(C14-alkoxy)-ethoxy]acetic acid
DP 15
410-640-6
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonic acid; sodium 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonate; potassium 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonate
INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1
reaction mass of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diyl-prop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diyl-prop-2-enoate
MONO 442
412-260-6
52658-19-2
Eye Irrit. 2; Skin Sens. 1
reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1); reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]and 2-methyl-4-isothiazolin-3-one [EC no. 220-239-6] (3:1)
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
reaction mass of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid; 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl)azo]benzoic acid
BONJET BLACK 817
418-230-9
163879-69-4
Expl. 1.3; Repr. 2; STOT RE 2; Skin Sens. 1
reaction mass of: 5-(N-methylperfluorooctylsulfonamido)methyl-3-octadecyl-1,3-oxazolidin-2-one; 5-(N-methylperfluoroheptylsulfonamido)methyl-3-octadecyl-1,3-oxazolidin-2-one
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
reaction mass of: 4-chloro-7-methylbenzotriazole sodium salt; 4-chloro-5-methylbenzotriazole sodium salt; 5-chloro-4-methylbenzotriazole sodium salt
427-730-6
202420-04-0
Skin Corr. 1B
reaction mass of: 4-amino-3-(4-ethenesulfonyl-2-sulfonatophenylazo)-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)naphthalene-2,7-disulfonate potassium/sodium; 4-amino-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-3-(2-sulfonato-4-(2-sulfonatooxyethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate potassium/sodium
451-440-9
586372-44-3
Eye Dam. 1
reaction mass of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
reaction mass of: 4-[[bis-(4-fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole; 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole
R 7623 TECHNICAL
403-250-2
-
Carc. 2; Repr. 1B; Acute Tox. 4
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