EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). 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).

RELEVANT LEGISLATION
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EU CLP (1272/2008)
Acute Tox. 2; STOT RE 2

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
Nickel triuranium decaoxide 239-876-6 15780-33-3 Expert judgement
Uranium pentafluoride 237-405-9 13775-07-0 Expert judgement
Triuranium tetraphosphide 234-871-5 12037-84-2 Expert judgement
Sodium uranyl triacetate, of uranium depleted in uranium-235 241-714-4 17712-38-8 Expert judgement
Zinc tetrakis(acetato-O)dioxouranate 251-762-8 33959-50-1 Expert judgement
Uranium nitrate - 13826-82-9 Expert judgement
[oxalato(2-)-O,O']dioxouranium 217-986-5 2031-89-2 Expert judgement
Disodium heptaoxodiuranate, of uranium depleted in uranium-235 237-286-3 13721-34-1 Expert judgement
Uranium dioxide 215-700-3 1344-57-6 Expert judgement
Uranium tetraboride 234-520-6 12007-84-0 Expert judgement
Uranium tetraiodide 236-735-0 13470-22-9 Expert judgement
Uranium triiodide 237-406-4 13775-18-3 Expert judgement
Zinc bis(acetato-O)dioxouranate 233-390-8 10138-94-0 Expert judgement
Nitric acid, uranium(6+) salt - 20820-60-4 Expert judgement
Uranium tetrafluoride 233-170-1 10049-14-6 Expert judgement
Tetraammonium uranyl tricarbonate, of uranium depleted in uranium-235 241-988-5 18077-77-5 Expert judgement
Calcium diuranium heptaoxide 237-428-4 13780-21-7 Expert judgement
Titanate(4-), oxobis[phosphato(3-)]-, barium (1:2), uranium-doped 309-550-9 100403-10-9 Expert judgement
Nickel uranyl tetraacetate, of uranium depleted in uranium-235 275-994-4 71767-12-9 Expert judgement
Triuranium octaoxide 215-702-4 1344-59-8 Expert judgement
Bis(nitrato-O,O')dioxouranium 253-053-9 36478-76-9 Expert judgement
Sodium tris(benzeneacetato-O)dioxouranate(1-) 309-040-6 99800-13-2 Expert judgement
Uranium diboride 234-508-0 12007-36-2 Expert judgement
Uranium fluoride (U2F9) - 12134-48-4 Expert judgement
Magnesium uranium(4+) hexaacetate 243-905-8 20596-93-4 Expert judgement
Bis(2-ethylhexanoato-O)dioxouranium 267-849-9 67939-77-9 Expert judgement
Uranium hydride (UH3) - 13598-56-6 Expert judgement
Bis(acetato-O)dioxouranium 208-767-5 541-09-3 Expert judgement
Uranium nitride - 12058-37-6 Expert judgement
Uranium hexafluoride 232-028-6 7783-81-5 Expert judgement
Diammonium diuranium heptaoxide 231-986-2 7783-22-4 Expert judgement
Lead uranate pigment 287-565-9 85536-79-4 Expert judgement
Hydrogen dioxo[phosphato(3-)-O,O']uranate(1-) 242-306-9 18433-48-2 Expert judgement
Uranium diselenide 235-245-4 12138-21-5 Expert judgement
Uranium tetrachloride 233-057-7 10026-10-5 Expert judgement
Tetrakis(pentane-2,4-dionato-O,O')uranium 265-498-6 65137-03-3 Expert judgement
Difluorodioxouranium 236-898-8 13536-84-0 Expert judgement
Dioxobis(pentane-2,4-dionato-O,O')uranium 241-951-3 18039-69-5 Expert judgement
polysilicate - 12427-14-4 Expert judgement
Uranium hydride 257-346-2 51680-55-8 Expert judgement
Barium uranium oxide - 10380-31-1 Expert judgement
Uranium tetrabromide 236-734-5 13470-20-7 Expert judgement
Magnesium diuranium heptaoxide 236-982-4 13568-61-1 Expert judgement
Uranium trifluoride 237-404-3 13775-06-9 Expert judgement
Uranium ditelluride 235-249-6 12138-37-3 Expert judgement
Uranium disulphide 234-884-6 12039-14-4 Expert judgement
Uranium disilicide 234-906-4 12039-85-9 Expert judgement
Bis(formato-O)dioxouranium 241-063-6 16984-59-1 Expert judgement
Oxobis(pentane-2,4-dionato-O,O')uranium 254-311-3 39136-40-8 Expert judgement
Uranium trioxide 215-701-9 1344-58-7 Expert judgement
Disodium uranium tetraoxide 236-846-4 13510-99-1 Expert judgement
Uranium dioxideperoxide 234-852-1 12036-71-4 Expert judgement
Dioxo[sulphato(2-)-O]uranium 215-240-3 1314-64-3 Expert judgement
Calcines, uranium ore-conc.
Calcined precipitates of ammonium, magnesium or sodium uranates obtained from natural uranium ores.
 297-819-0 93763-02-1 Expert judgement
Uranium carbide (UC2) - 12071-33-9 Expert judgement
Dipotassium heptaoxodiuranate 232-217-3 7790-63-8 Expert judgement
Resin acids and Rosin acids, uranyl salts 273-325-0 68956-97-8 Expert judgement
Dichlorodioxouranium 232-246-1 7791-26-6 Expert judgement
Uranium 231-170-6 7440-61-1 Expert judgement
Dipotassium uranyl bis(sulphate), of uranium depleted in uranium-235 262-284-4 60542-74-7 Expert judgement
Bis(nitrato-O)dioxouranium 233-266-3 10102-06-4 Expert judgement
Acetic acid, uranium(4+) zinc salt 243-904-2 20596-91-2 Expert judgement