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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 16 April 2024. Database contains 4821 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
Trypanosoma cruzi
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P Parasites
uranium compounds with the exception of those specified elsewhere in this Annex
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Uranium disilicide EC / List no: 234-906-4 | CAS no: 12039-85-9
Titanate(4-), oxobis[phosphato(3-)]-, barium (1:2), uranium-doped EC / List no: 309-550-9 | CAS no: 100403-10-9
Bis(acetato-O)dioxouranium EC / List no: 208-767-5 | CAS no: 541-09-3
Uranium tetrafluoride EC / List no: 233-170-1 | CAS no: 10049-14-6
Barium uranium oxide EC / List no: - | CAS no: 10380-31-1
Uranium diselenide EC / List no: 235-245-4 | CAS no: 12138-21-5
Uranium tetrachloride EC / List no: 233-057-7 | CAS no: 10026-10-5
Bis(nitrato-O)dioxouranium EC / List no: 233-266-3 | CAS no: 10102-06-4
Bis(formato-O)dioxouranium EC / List no: 241-063-6 | CAS no: 16984-59-1
Disodium uranium tetraoxide EC / List no: 236-846-4 | CAS no: 13510-99-1
Uranium hydride (UH3) EC / List no: - | CAS no: 13598-56-6
Uranium ditelluride EC / List no: 235-249-6 | CAS no: 12138-37-3
Uranium trifluoride EC / List no: 237-404-3 | CAS no: 13775-06-9
Uranium hexafluoride EC / List no: 232-028-6 | CAS no: 7783-81-5
Uranium fluoride (U2F9) EC / List no: - | CAS no: 12134-48-4
Uranium pentafluoride EC / List no: 237-405-9 | CAS no: 13775-07-0
Uranium dioxide EC / List no: 215-700-3 | CAS no: 1344-57-6
Triuranium tetraphosphide EC / List no: 234-871-5 | CAS no: 12037-84-2
Sodium uranyl triacetate, of uranium depleted in uranium-235 EC / List no: 241-714-4 | CAS no: 17712-38-8
Tetraammonium uranyl tricarbonate, of uranium depleted in uranium-235 EC / List no: 241-988-5 | CAS no: 18077-77-5
Uranium dioxideperoxide EC / List no: 234-852-1 | CAS no: 12036-71-4
Difluorodioxouranium EC / List no: 236-898-8 | CAS no: 13536-84-0
Triuranium octaoxide EC / List no: 215-702-4 | CAS no: 1344-59-8
Nickel uranyl tetraacetate, of uranium depleted in uranium-235 EC / List no: 275-994-4 | CAS no: 71767-12-9
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
Uranyl acetate-2H2O EC / List no: 629-550-5 | CAS no: 6159-44-0
Magnesium uranium(4+) hexaacetate EC / List no: 243-905-8 | CAS no: 20596-93-4
Uranium trioxide EC / List no: 215-701-9 | CAS no: 1344-58-7
Hydrogen dioxo[phosphato(3-)-O,O']uranate(1-) EC / List no: 242-306-9 | CAS no: 18433-48-2
Uranium tetraiodide EC / List no: 236-735-0 | CAS no: 13470-22-9
Resin acids and Rosin acids, uranyl salts EC / List no: 273-325-0 | CAS no: 68956-97-8
Sodium tris(benzeneacetato-O)dioxouranate(1-) EC / List no: 309-040-6 | CAS no: 99800-13-2
Uranate(2-), tetrakis(acetato-O)-dioxo-, magnesium (1:1), (OC-6-11)- EC / List no: - | CAS no: 66735-86-2
Nitric acid, uranium(6+) salt EC / List no: - | CAS no: 20820-60-4
Uranium tetraboride EC / List no: 234-520-6 | CAS no: 12007-84-0
Uranium hydride EC / List no: 257-346-2 | CAS no: 51680-55-8
[oxalato(2-)-O,O']dioxouranium EC / List no: 217-986-5 | CAS no: 2031-89-2
Zinc bis(acetato-O)dioxouranate EC / List no: 233-390-8 | CAS no: 10138-94-0
Bis(nitrato-O,O')dioxouranium EC / List no: 253-053-9 | CAS no: 36478-76-9
Bis(2-ethylhexanoato-O)dioxouranium EC / List no: 267-849-9 | CAS no: 67939-77-9
Uranium nitride EC / List no: - | CAS no: 12058-37-6
Calcium diuranium heptaoxide EC / List no: 237-428-4 | CAS no: 13780-21-7
Dichlorodioxouranium EC / List no: 232-246-1 | CAS no: 7791-26-6
Zinc tetrakis(acetato-O)dioxouranate EC / List no: 251-762-8 | CAS no: 33959-50-1
Lead uranate pigment EC / List no: 287-565-9 | CAS no: 85536-79-4
Magnesium diuranium heptaoxide EC / List no: 236-982-4 | CAS no: 13568-61-1
Uranium disulphide EC / List no: 234-884-6 | CAS no: 12039-14-4
polysilicate EC / List no: - | CAS no: 12427-14-4
Nasturan EC / List no: 690-098-7 | CAS no: 1317-99-3
Nitric acid, uranium salt EC / List no: - | CAS no: 15905-86-9
Disodium heptaoxodiuranate, of uranium depleted in uranium-235 EC / List no: 237-286-3 | CAS no: 13721-34-1
Uranium EC / List no: 231-170-6 | CAS no: 7440-61-1
Uranium diboride EC / List no: 234-508-0 | CAS no: 12007-36-2
Uranium triiodide EC / List no: 237-406-4 | CAS no: 13775-18-3
Tetrakis(pentane-2,4-dionato-O,O')uranium EC / List no: 265-498-6 | CAS no: 65137-03-3
Acetic acid, uranium(4+) zinc salt EC / List no: 243-904-2 | CAS no: 20596-91-2
Uranium tetrabromide EC / List no: 236-734-5 | CAS no: 13470-20-7
Dipotassium uranyl bis(sulphate), of uranium depleted in uranium-235 EC / List no: 262-284-4 | CAS no: 60542-74-7
Uranium carbide (UC2) EC / List no: - | CAS no: 12071-33-9
Diammonium diuranium heptaoxide EC / List no: 231-986-2 | CAS no: 7783-22-4
Dioxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 241-951-3 | CAS no: 18039-69-5
Uranium carbide (UC) EC / List no: - | CAS no: 12070-09-6
Dioxo[sulphato(2-)-O]uranium EC / List no: 215-240-3 | CAS no: 1314-64-3
Oxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 254-311-3 | CAS no: 39136-40-8
Uranium nitrate EC / List no: - | CAS no: 13826-82-9
Dipotassium heptaoxodiuranate EC / List no: 232-217-3 | CAS no: 7790-63-8
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Acute Tox. 2; STOT RE 2
Vaccinia virus
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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.
Variant Creutzfeldt-Jakob disease
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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.
Variola (major and minor) virus
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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.
Venezuelan equine encephalomyelitis
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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.
Vesicular stomatitis virus
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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.
Vibrio cholerae (including El Tor)
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B Bacteria and similar species
Vibrio parahaemolyticus
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B Bacteria and similar species
Vibrio spp.
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B Bacteria and similar species
Wesselsbron virus
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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.
West Nile fever virus
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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.
Western equine encephalomyelitis
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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.
Whitepox virus
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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.
Wuchereria bancrofti
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-
P Parasites
Yatapox virus
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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.
Yellow fever
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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.
Yersinia enterocolitica
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B Bacteria and similar species
Yersinia pestis
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B Bacteria and similar species
Yersinia pseudotuberculosis
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B Bacteria and similar species
Yersinia spp.
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B Bacteria and similar species
zinc chromates including zinc potassium chromate
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Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
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Carc. 1A; Acute Tox. 4; Skin Sens. 1
'amyl nitrite', mixed isomers
203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
(1α,2α,3β,6β)-1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
(2-ethylhexanoato-O)(isodecanoato-O)nickel
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2-ethylhexanoato-O)(isononanoato-O)nickel
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2R,6aS,12aS)-1,2,6,6a,12,12a-hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one, rotenone
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
(3-chloro-2-hydroxypropyl); trimethylammonium chloride ...%
222-048-3
3327-22-8
Carc. 2
(4-ammonio-m-tolyl)ethyl(2-hydroxyethyl)ammonium sulphate; 4-(N-ethyl-N-2-hydroxyethyl)-2-methylphenylenediamine sulphate
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
(benzothiazol-2-ylthio)methyl thiocyanate; TCMTB
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
(E)-2-butenal; (E)-crotonaldehyde
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
(E)-2-methoxy-4-(prop-1-enyl)phenol
227-678-2
5932-68-3
Skin Sens. 1A
(E)-but-2-ene
210-855-3
624-64-6
Flam. Gas 1; Press. Gas
(isodecanoato-O)(isononanoato-O)nickel
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isodecanoato-O)(isooctanoato-O)nickel
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isononanoato-O)(isooctanoato-O)nickel
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isononanoato-O)(neodecanoato-O)nickel
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isooctanoato-O)(neodecanoato-O)nickel
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(R)-4-hydroxy-3-(3-oxo-1-phenylbutyl)-2-benzopyrone
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
(R)-butan-2-ol
238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(R)-p-mentha-1,8-diene; d-limonene
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
(R)-sec-butylamine; (R)-2-aminobutane
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
(S)-4-hydroxy-3-(3-oxo-1-phenylbutyl)-2-benzopyrone
226-907-3
5543-57-7
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
(S)-butan-2-ol
224-168-1
4221-99-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(S)-p-mentha-1,8-diene; l-limonene
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(S)-sec-butylamine; (S)-2-aminobutane
208-164-7
513-49-5
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
(Z)-1,3-dichloropropene
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
(Z)-2-methoxy-4-(prop-1-enyl)phenol
227-633-7
5912-86-7
Skin Sens. 1A
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