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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
Lubricating oils; Baseoil — unspecified [ complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.]
A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.
278-012-2
74869-22-0
Carc. 1B
Lubricating greases; Grease [A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.]
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.
278-011-7
74869-21-9
Carc. 1B
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine
277-985-0
74753-18-7
Carc. 1B; Acute Tox. 4
aclonifen (ISO); 2-chloro-6-nitro-3-phenoxyaniline
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
Extract residues (coal), tar oil alk., naphthalene distn. residues; Naphthalene Oil Extract Residue [he residue obtained from chemical oil extracted after the removal of naphthalene by distillation composed primarily of two to four membered condensed ring aromatic hydrocarbons and aromatic nitrogen bases.]
The residue obtained from chemical oil extracted after the removal of naphthalene by distillation composed primarily of two to four membered condensed ring aromatic hydrocarbons and aromatic nitrogen bases.
277-567-8
73665-18-6
Carc. 1B; Muta. 1B
menadione nicotinamide bisulfite; 1,2,3,4-tetrahydro-2-methyl-1,4-dioxonaphthalene-2-sulfonicacid, compound with nicotin-3-amide (1:1)
277-543-7
73581-79-0
Eye Irrit. 2; Skin Irrit. 2
rosin; colophony
277-299-1
73138-82-6
Skin Sens. 1
Pentacosafluorotridecanoic acid
276-745-2
72629-94-8
yes
Phenol, heptyl derivs.
276-743-1
72624-02-3
yes
Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32cSt at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.]
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-738-4
72623-87-1
Carc. 1B
Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40 °C. It contains a relatively large proportion of saturated hydrocabons.]
A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-737-9
72623-86-0
Carc. 1B
Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and; solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of approximately 112cSt at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.]
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of approximately 112cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-736-3
72623-85-9
Carc. 1B
fenoxycarb (ISO); ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
276-696-7
72490-01-8
Carc. 2
fomesafen (ISO); 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulphonyl)-2-nitrobenzamide
276-439-9
72178-02-0
Acute Tox. 4
2,4(or 2,5)-xylenol
276-245-4
71975-58-1
Acute Tox. 3; Skin Corr. 1B
bis(d-gluconato-O1,O2)nickel
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
1,2-benzenedicarboxylic acid; di-C6-8-branched alkylesters, C7-rich
276-158-1
71888-89-6
Repr. 1B
yes
diisohexyl phthalate
276-090-2
71850-09-4
Repr. 1B
yes
ethyl hydrogen sulfate, nickel(II) salt
275-897-7
71720-48-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
2,4(or 2,6)-dinitrophenol
275-732-9
71629-74-8
Acute Tox. 3; STOT RE 2
nickel zirkonium trioxide
274-755-1
70692-93-2
Carc. 1A; STOT RE 1; Skin Sens. 1
2-methoxypropyl acetate
274-724-2
70657-70-4
Flam. Liq. 3; Repr. 1B; STOT SE 3
Distillates (petroleum), vacuum; Heavy Fuel oil [A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having numbers predominantly in the range of C15 through C50 and boiling in the range of approximately 270 °C to 600 °C (518°F to 1112 °F). This stream is likely to contain 5 wt.% or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and boiling in the range of approximately 270°C to 600°C (518°F to 1112°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
274-685-1
70592-78-8
Carc. 1B
Distillates (petroleum), light vacuum; Heavy Fuel oil [A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C35 and boiling in the range of approximately 250 °C to 545°C (482°F to 1013 °F).]
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C35 and boiling in the range of approximately 250°C to 545°C (482°F to 1013°F).
274-684-6
70592-77-7
Carc. 1B
Distillates (petroleum), intermediate vacuum; Heavy Fuel oil [A complex combination of hydrocarbons produced by the vacuum, distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C14 through C42 and boiling in the range of approximately 250°C to 545°C (482°F to 1013°F). This stream is likely to contain 5 wt. % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C14 through C42 and boiling in the range of approximately 250°C to 545°C (482°F to 1013°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
274-683-0
70592-76-6
Carc. 1B
Creosote oil, low-boiling distillate; Wash Oil [he low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38 o C (100 oF).]
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
Creosote oil, high-boiling distillate; Wash Oil [The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5 °C (41°F).]
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
Tar bases, coal, quinoline derivs. fraction; Distillate Bases
274-560-1
70321-67-4
Carc. 1B; Muta. 1B
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1)
274-462-9
70225-16-0
yes
diethanolamine perfluorooctane sulfonate
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
fluazifop-butyl (ISO); butyl (RS)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
274-125-6
69806-50-4
Repr. 1B
cyprofuram (ISO); N-(3-chlorophenyl)-N-(tetrahydro-2-oxo-3-furyl)cyclopropanecarboxamide
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
nickel matte
Product of blowing smelted nickel ore in a converter to lower the iron content.
273-749-6
69012-50-6
Carc. 1A; STOT RE 1; Skin Sens. 1
[Phthalato(2-)]dioxotrilead
273-688-5
69011-06-9
yes
Tar, coal, high-temp., high-solids; Coal Tar Solids Residue [The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700 °C (1292 °F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal-type materials.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
Gases (petroleum), crude distn. and catalytic cracking; Refinery gas [ complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulfide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulfide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-563-5
68989-88-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Residues (petroleum), steam-cracked, resinous; Heavy Fuel oil [A complex residuum from the distillation of steam-cracked petroleum residues.]
A complex residuum from the distillation of steam-cracked petroleum residues.
273-272-3
68955-36-2
Carc. 1B
Naphtha (petroleum), catalytic reformed; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30 °C to 220 °C (90°F to 430°F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.]
A complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 220°C (90°F to 430°F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.
273-271-8
68955-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gases (petroleum), straight-run naphtha catalytic reformer stabilizer overhead; Petroleum gas [ complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the frac tionation of the total effluent.; It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.]
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.
273-270-2
68955-34-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), sponge absorber off, fluidized catalytic cracker and gas oil desulfurizer overhead fractionation; Refinery gas [ complex combination obtained by the fractionation of products from the fluidized catalytic cracker and gas oil desulfurizer. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination obtained by the fractionation of products from the fluidized catalytic cracker and gas oil desulfurizer. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-269-7
68955-33-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Distillates (petroleum), light thermal cracked, debutanized arom.; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.]
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.
273-266-0
68955-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gases (petroleum, light steam-cracked, butadiene conc.; Petroleum gas [ complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.]
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.
273-265-5
68955-28-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Distillates (petroleum), petroleum residues vacuum; Heavy Fuel oil [A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from the atmospheric distillation of crude oil.]
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from the atmospheric distillation of crude oil.
273-263-4
68955-27-1
Carc. 1B
Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabilizer, petroleum coking; Petroleum gas [ complex combination of hydrocarbons obtained from the fractionation stabilization of thermal cracked hydrocarbons from petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination of hydrocarbons obtained from the fractionation stabilization of thermal cracked hydrocarbons from petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-176-1
68952-82-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber; petroleum gas [ complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists pedrominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-175-6
68952-81-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), straight-run naphtha hydrodesulfurizer; Refinery gas [ complex combination obtained from the hydrodesulfurization of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination obtained from the hydrodesulfurization of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
273-174-0
68952-80-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator; Refinery gas [ complex combination of hydrocarbons obtained from the hydrodesulfurization of naphtha. It consists of hydrogen, methane, ethane, and propane.]
A complex combination of hydrocarbons obtained from the hydrodesulfurization of naphtha. It consists of hydrogen, methane, ethane, and propane.
273-173-5
68952-79-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer; Petroleum gas [ complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-170-9
68952-77-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), catalytic cracked naphtha debutanizer; Petroleum gas [ complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-169-3
68952-76-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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