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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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: (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: 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'-[[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: 2,4,6-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-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-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: 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: 4,7-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol; 4,8-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol; 5,7-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
reaction mass of: 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinol-4-yl-tris(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate); 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate) (2:1)
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
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: 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: branched icosane; branched docosane; branched tetracosane
417-050-8
151006-58-5
Acute Tox. 4
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: 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: 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: 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: 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: 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: 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: 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: 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: pentasodium; 5-amino-3-(5-{4-chloro-6-[4-(2-sulfoxyethoxysulfonato)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-6-[5-(2,3-dibromopropionylamino)-2-sulfonatophenylazo]-4-hydroxynaphthalene-2,7-disulfonate; pentasodium 5-amino-6-[5-(2-bromoacryloylamino)-2-sulfonatophenylazo]-3-(5-{4-chloro-6-[4-(2-sulfoxyethoxysulfonato)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-4-hydroxynaphthalene-2,7-disulfonate; tetrasodium 5-amino-3-[5-{4-chloro-6-[4-(vinylsulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo]-6-[5-(2,3-dibromopropionylamino)-2-sulfonatophenylazo]-4-hydroxynaphthalene-2,7-disulfonate
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
reaction mass of: reaction product of 4,4'-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2); reaction product of 4,4'-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:3)
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
reaction mass of: sodium 5-[8-[4-[4-[4-[7-(3,5-dicarboxylatophenylazo)-8-hydroxy-3,6-disulfonatonaphthalen-1-ylamino]-6-hydroxy-1,3,5-triazin-2-yl]-2,5-dimethylpiperazin-1-yl]-6-hydroxy-1,3,5-triazin-2-ylamino]-1-hydroxy-3,6-disulfonatonaphthalen-2-ylazo]-isophthalate; ammonium 5-[8-[4-[4-[4-[7-(3,5-dicarboxylatophenylazo)-8-hydroxy-3,6-disulfonatonaphthalen-1-ylamino]-6-hydroxy-1,3,5-triazin-2-yl]-2,5-dimethylpiperazin-1-yl]-6-hydroxy-1,3,5-triazin-2-ylamino]-1-hydroxy 3,6-disulfonatonaphthalen-2-ylazo]-isophthalate; 5-[8-[4-[4-[4-[7-(3,5-dicarboxylatophenylazo)-8-hydroxy-3,6-disulfonatonaphthalen-1-ylamino]-6-hydroxy-1,3,5-triazin-2-yl]-2,5-dimethylpiperazin-1-yl]-6-hydroxy-1,3,5-triazin-2-ylamino]-1-hydroxy-3,6-disulfonaphthalen-2-ylazo]-isophthalic acid
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
reaction mass of: sodium/potassium 7-[[[3-[[4-((2-hydroxy-naphthyl)azo)phenyl]azo]phenyl]sulfonyl]amino]-naphthalene-1,3-disulfonate
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
reaction mass of: tetradecanoic acid (42,5-47,5 %); poly(1-7)lactate esters of tetradecanoic acid (52,5-57,5 %)
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: tetrasodium 7-(4-[4-chloro-6-[methyl-(3-sulfonatophenyl)amino]-1,3,5-triazin-2-ylamino]-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate; tetrasodium 7-(4-[4-chloro-6-[methyl-(4-sulfonatophenyl)amino]-1,3,5-triazin-2-ylamino]-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate (1:1)
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 1
reaction mass of: thiobis(4,1-phenylene)-S, S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate; propylene carbonate
CYRACURE PHOTOINITIATOR UVI-6990; CYRACURE PHOTOINITIATOR UVI-6992
403-490-8
104558-95-4
Eye Irrit. 2; Skin Sens. 1
reaction mass of: trans-(2R)-5-acetoxy-1,3-oxathiolane-2-carboxylic acid; cis-(2R)-5-acetoxy-1,3-oxathiolane-2-carboxylic acid
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: trans-2-(1-methylethyl)-1,3-dioxane-5-carboxylic acid; cis-2-(1-methylethyl)-1,3-dioxane-5-carboxylic acid
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
reaction mass of: trans-trans-cyclohexadeca-1,9-diene; cis-trans-cyclohexadeca-1,9-diene
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
reaction mass of: trilithium 4-amino-3-((4-((4-((2-amino-4-hydroxyphenyl)azo)phenyl)amino)-3-sulfophenyl)azo)5-hydroxy-6-(phenylazo)naphthalene-2,7-disulfonate; trilithium 4-amino-3-((4-((4-((4-amino-2-hydroxyphenyl)azo)phenyl)amino)-3-sulfophenyl)azo)-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulfonate
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
reaction mass of: tris(3,5,5-trimethylhexylammonium) 4-amino-3-(4-(4-(2-amino-4-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate; tris(3,5,5-trimethylhexylammonium) 4-amino-3-(4-(4-(4-amino-2-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate (2:1)
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
reaction mass of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
ADDITIV 104
412-780-3
1380226-46-9
Skin Irrit. 2; Skin Sens. 1
reaction product of amorphous silica (50-85 %), butyl (1-methylpropyl) magnesium (3-15 %), tetraethyl orthosilicate (5-15 %) and titanium tetrachloride (5-20 %)
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Reaction product of: 1,2,3-propanetricarboxylic acid, 2-hydroxy, diethyl ester, 1-propanol and zirconium tetra-n-propanolate
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)
939-460-0
1471311-26-8
yes
reaction products of 3,10-bis((2-aminopropyl)amino)-6,13-dichloro-4,11-triphenodioxazinedisulfonic acid with 2-amino-1,4-benzenedisulfonic acid, 2-((4-aminophenyl)sulfonyl)ethyl hydrogen sulfate and 2,4,6-trifluoro-1,3,5-triazine, sodium salts
426-860-0
191877-09-5
Eye Dam. 1
reaction products of tungsten hexachloride with 2-methylpropan-2-ol, nonylphenol and pentane-2,4-dione
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction products of: aniline-terephthalaldehyde-o-toluidine condensate with maleic anhydride
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
reaction products of: trimethylhexamethylene diamine (a mixture of 2,2,4-trimethyl-1,6-hexanediamine and 2,4,4-trimethyl-1,6-hexanediamine, EINECS listed), Epoxide 8 (mono[(C10-C16-alkyloxy)methyl]oxirane derivatives) and p-toluene-sulfonic acid
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
Residual oils (petroleum), carbon-treated solvent-dewaxed; Baseoil — unspecified [ complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.]
A complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.
309-710-8
100684-37-5
Carc. 1B
Residual oils (petroleum), clay-treated solvent-dewaxed; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.]
A complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.
309-711-3
100684-38-6
Carc. 1B
Residues (petroleum), steam-cracked light, arom.; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by the distillation of the products of steamcracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40o C (104°F).]
A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40°C (104°F).
310-057-6
102110-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
resmethrin (ISO);5-benzyl-3-furylmethyl (±)-cis-trans-chrysanthemate
233-940-7
10453-86-8
Acute Tox. 4
resorcinol; 1,3-benzenediol
203-585-2
108-46-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
S-ethyl N-(dimethylaminopropyl)thiocarbamatehydrochloride; prothiocarb hydrochloride
243-193-9
19622-19-6
Acute Tox. 4
salt of: (1S-cis)-1-amino-2,3-dihydro-1H-inden-2-ol and [R-[R*R*]]-2,3-dihydroxybutanedioic acid
425-210-3
169939-84-8
Skin Sens. 1
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