EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.
Last updated 13 rujna 2024. Database contains 4821 unique substances/entries.
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A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C25 and boiling in the range of approximately 160°C to 400°C (320°F to 725°F). This stream is likely to contain 5 wt. % or more of 4- or 6-membered condensed ring aromatic hydrocarbons.
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265-069-3
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64741-67-9
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Carc. 1B |
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A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and light vacuum gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C(446°F).
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270-983-0
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68512-61-8
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Carc. 1B |
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A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F).
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265-076-1
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64741-75-9
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Carc. 1B |
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A complex combination of hydrocarbons obtained by treating an atmospheric tower residuum with hydrogen in the presence of a catalyst under conditions primarily to remove organic sulfur compounds. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-181-2
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64742-78-5
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Carc. 1B |
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A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C (32°F to 662°F).
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295-514-7
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92062-00-5
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Carc. 1B |
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A complex combination of hydrocarbons obtained as residue from the distillation of steam cracked heat soaked naphtha and boiling in the range of approximately 150°C to 350°C (302°F to 662°F).
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297-905-8
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93763-85-0
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Carc. 1B |
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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).
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310-057-6
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102110-55-4
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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A complex residuum from the distillation of the products from a steam-cracking process. It consists predominantly of aromatic and unsaturated hydrocarbons having carbon numbers greater than C7 and boiling in the range of approximately 101°C to 555°C (214°F to 1030°F).
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271-013-9
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68513-69-9
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Carc. 1B |
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A complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temperature. It boils in the range of approximately 147°C to 300°C (297°F to 572°F) and produces a finished oil having a viscosity of 18cSt at 50°C.
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295-517-3
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92062-04-9
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Carc. 1B |
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A complex combination of hydrocarbons obtained during the production of refined petroleum tar by the distillation of steam cracked tar. It consists predominantly of aromatic and other hydrocarbons and organic sulfur compounds.
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292-657-7
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90669-75-3
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Carc. 1B |
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A complex residuum from the distillation of steam-cracked petroleum residues.
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273-272-3
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68955-36-2
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Carc. 1B |
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A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C14 and boiling above approximately 260°C (500°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-193-8
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64742-90-1
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Carc. 1B |
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A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-081-9
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64741-80-6
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Carc. 1B |
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A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.
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271-763-7
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68607-30-7
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Carc. 1B |
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A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390°C (734°F).
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292-658-2
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90669-76-4
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Carc. 1B |
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A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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272-187-9
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68783-13-1
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Carc. 1B |
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A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
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270-984-6
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68512-62-9
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Carc. 1B |
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A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
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308-733-0
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98219-64-8
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Carc. 1B |
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A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
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270-796-4
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68478-17-1
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Carc. 1B |
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233-940-7
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10453-86-8
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Acute Tox. 4 |
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203-585-2
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108-46-3
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Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
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232-475-7
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8050-09-7
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Skin Sens. 1 |
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A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
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232-484-6
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8052-10-6
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Skin Sens. 1 |
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277-299-1
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73138-82-6
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Skin Sens. 1 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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R-GLYCIDOL
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404-660-4
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57044-25-4
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Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B |
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436-690-9
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220727-26-4
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Skin Sens. 1 |
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ALKYL ISOCYANATE SILANE SCD 617
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402-290-8
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85702-90-5
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Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1 |
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953-17-3
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Acute Tox. 3 |
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620-370-2
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2703-37-9
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Acute Tox. 2; Acute Tox. 1 |
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2635-50-9
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Acute Tox. 3 |
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249-013-5
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28434-00-6
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Acute Tox. 4 |
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243-193-9
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19622-19-6
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Acute Tox. 4 |
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