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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 120°C (158°F to 248°F).
309-745-9
100801-63-6
Carc. 1B; Muta. 1B
600-130-3
100784-20-1
Repr. 1B
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.
309-723-9
100684-49-9
Carc. 1B
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
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
A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.
309-706-6
100684-33-1
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-675-9
100684-05-7
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-674-3
100684-04-6
Carc. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum with bleaching earth for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-669-6
100683-99-6
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-668-0
100683-98-5
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of a petroleum oil fraction with activated charcoal for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C28.
309-667-5
100683-97-4
Carc. 1B
233-195-8
10061-01-5
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
DM-8
405-880-3
100501-62-0
Skin Sens. 1
422-360-1
100491-29-0
Skin Sens. 1
233-162-8
10049-04-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
233-162-8
10049-04-4
Acute Tox. 3; Skin Corr. 1B
233-154-4
10046-00-1
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
233-140-8
10043-52-4
Eye Irrit. 2
233-139-2
10043-35-3
Repr. 1B
yes
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; STOT SE 3
233-113-0
10035-10-6
Skin Corr. 1B; STOT SE 3
233-109-9
10034-85-2
Skin Corr. 1B
233-109-9
10034-85-2
Press. Gas; Skin Corr. 1A
233-071-3
10028-18-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
233-054-0
10026-04-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
233-047-2
10025-91-9
Skin Corr. 1B
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
233-036-2
10025-67-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
233-002-7
10007-85-9
Eye Irrit. 2
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
CG 24-020; FERROCEN-SBF6
407-840-0
100011-37-8
Acute Tox. 4; Eye Dam. 1
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
202-905-8
100-97-0
Flam. Sol. 2; Skin Sens. 1
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
202-860-4
100-52-7
Acute Tox. 4
202-859-9
100-51-6
Acute Tox. 4
202-855-7
100-47-0
Acute Tox. 4
202-854-1
100-46-9
Acute Tox. 4; Skin Corr. 1B
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
202-848-9
100-40-3
Carc. 2
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-831-6
100-22-1
Acute Tox. 4
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
202-810-1
100-01-6
Acute Tox. 3; STOT RE 2
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
936-037-2
-
yes
425-240-7
-
Eye Dam. 1
show/hide
Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
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Carc. 1A; Acute Tox. 4; Skin Sens. 1
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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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P Parasites
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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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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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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.
-
-
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.
-
-
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.
show/hide
Titanate(4-), oxobis[phosphato(3-)]-, barium (1:2), uranium-doped EC / List no: 309-550-9 | CAS no: 100403-10-9
Bis(nitrato-O)dioxouranium EC / List no: 233-266-3 | CAS no: 10102-06-4
Uranium disulphide EC / List no: 234-884-6 | CAS no: 12039-14-4
Hydrogen dioxo[phosphato(3-)-O,O']uranate(1-) EC / List no: 242-306-9 | CAS no: 18433-48-2
Acetic acid, uranium(4+) zinc salt EC / List no: 243-904-2 | CAS no: 20596-91-2
Sodium uranyl triacetate, of uranium depleted in uranium-235 EC / List no: 241-714-4 | CAS no: 17712-38-8
Nickel uranyl tetraacetate, of uranium depleted in uranium-235 EC / List no: 275-994-4 | CAS no: 71767-12-9
Uranium ditelluride EC / List no: 235-249-6 | CAS no: 12138-37-3
Uranium hydride (UH3) EC / List no: - | CAS no: 13598-56-6
Uranium tetrachloride EC / List no: 233-057-7 | CAS no: 10026-10-5
Uranium trifluoride EC / List no: 237-404-3 | CAS no: 13775-06-9
Zinc tetrakis(acetato-O)dioxouranate EC / List no: 251-762-8 | CAS no: 33959-50-1
Triuranium octaoxide EC / List no: 215-702-4 | CAS no: 1344-59-8
Uranium fluoride (U2F9) EC / List no: - | CAS no: 12134-48-4
Uranium tetraboride EC / List no: 234-520-6 | CAS no: 12007-84-0
Uranium trioxide EC / List no: 215-701-9 | CAS no: 1344-58-7
Dioxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 241-951-3 | CAS no: 18039-69-5
Uranium tetrabromide EC / List no: 236-734-5 | CAS no: 13470-20-7
Uranium hydride EC / List no: 257-346-2 | CAS no: 51680-55-8
Resin acids and Rosin acids, uranyl salts EC / List no: 273-325-0 | CAS no: 68956-97-8
Dipotassium uranyl bis(sulphate), of uranium depleted in uranium-235 EC / List no: 262-284-4 | CAS no: 60542-74-7
Uranium nitrate EC / List no: - | CAS no: 13826-82-9
Triuranium tetraphosphide EC / List no: 234-871-5 | CAS no: 12037-84-2
polysilicate EC / List no: - | CAS no: 12427-14-4
Barium uranium oxide EC / List no: - | CAS no: 10380-31-1
Uranium nitride EC / List no: - | CAS no: 12058-37-6
Dipotassium heptaoxodiuranate EC / List no: 232-217-3 | CAS no: 7790-63-8
Uranium dioxideperoxide EC / List no: 234-852-1 | CAS no: 12036-71-4
Tetraammonium uranyl tricarbonate, of uranium depleted in uranium-235 EC / List no: 241-988-5 | CAS no: 18077-77-5
Lead uranate pigment EC / List no: 287-565-9 | CAS no: 85536-79-4
Uranium diboride EC / List no: 234-508-0 | CAS no: 12007-36-2
Magnesium uranium(4+) hexaacetate EC / List no: 243-905-8 | CAS no: 20596-93-4
Uranium dioxide EC / List no: 215-700-3 | CAS no: 1344-57-6
Sodium tris(benzeneacetato-O)dioxouranate(1-) EC / List no: 309-040-6 | CAS no: 99800-13-2
Uranium disilicide EC / List no: 234-906-4 | CAS no: 12039-85-9
Bis(nitrato-O,O')dioxouranium EC / List no: 253-053-9 | CAS no: 36478-76-9
Disodium uranium tetraoxide EC / List no: 236-846-4 | CAS no: 13510-99-1
Oxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 254-311-3 | CAS no: 39136-40-8
Bis(acetato-O)dioxouranium EC / List no: 208-767-5 | CAS no: 541-09-3
Diammonium diuranium heptaoxide EC / List no: 231-986-2 | CAS no: 7783-22-4
Calcines, uranium ore-conc.
Calcined precipitates of ammonium, magnesium or sodium uranates obtained from natural uranium ores.
EC / List no: 297-819-0 | CAS no: 93763-02-1
Nickel triuranium decaoxide EC / List no: 239-876-6 | CAS no: 15780-33-3
Uranium EC / List no: 231-170-6 | CAS no: 7440-61-1
Uranium pentafluoride EC / List no: 237-405-9 | CAS no: 13775-07-0
Uranium diselenide EC / List no: 235-245-4 | CAS no: 12138-21-5
Dichlorodioxouranium EC / List no: 232-246-1 | CAS no: 7791-26-6
Difluorodioxouranium EC / List no: 236-898-8 | CAS no: 13536-84-0
[oxalato(2-)-O,O']dioxouranium EC / List no: 217-986-5 | CAS no: 2031-89-2
Uranium tetrafluoride EC / List no: 233-170-1 | CAS no: 10049-14-6
Uranium tetraiodide EC / List no: 236-735-0 | CAS no: 13470-22-9
Uranium hexafluoride EC / List no: 232-028-6 | CAS no: 7783-81-5
Bis(formato-O)dioxouranium EC / List no: 241-063-6 | CAS no: 16984-59-1
Calcium diuranium heptaoxide EC / List no: 237-428-4 | CAS no: 13780-21-7
Uranium carbide (UC2) EC / List no: - | CAS no: 12071-33-9
Disodium heptaoxodiuranate, of uranium depleted in uranium-235 EC / List no: 237-286-3 | CAS no: 13721-34-1
Magnesium diuranium heptaoxide EC / List no: 236-982-4 | CAS no: 13568-61-1
Zinc bis(acetato-O)dioxouranate EC / List no: 233-390-8 | CAS no: 10138-94-0
Nitric acid, uranium(6+) salt EC / List no: - | CAS no: 20820-60-4
Dioxo[sulphato(2-)-O]uranium EC / List no: 215-240-3 | CAS no: 1314-64-3
Uranium triiodide EC / List no: 237-406-4 | CAS no: 13775-18-3
Bis(2-ethylhexanoato-O)dioxouranium EC / List no: 267-849-9 | CAS no: 67939-77-9
Tetrakis(pentane-2,4-dionato-O,O')uranium EC / List no: 265-498-6 | CAS no: 65137-03-3
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Acute Tox. 2; STOT RE 2
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P Parasites
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P Parasites
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P Parasites
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P Parasites
RED JB 747
418-220-4
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Skin Sens. 1
TURQUOISE 10 40 518
411-430-7
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Eye Dam. 1; Skin Sens. 1
423-100-1
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Eye Dam. 1
BLUE TZ 4312
423-770-3
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Eye Dam. 1
show/hide
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
799-976-5
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yes
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Acute Tox. 3
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Acute Tox. 3
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Acute Tox. 2; Acute Tox. 1
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Acute Tox. 2; Acute Tox. 1
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P Parasites

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