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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 April 2024. Database contains 4821 unique substances/entries.
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Carc. 2 |
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232-589-7
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9001-22-3
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Resp. Sens. 1 |
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278-636-5
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77182-82-2
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Repr. 1B; Acute Tox. 4; STOT RE 2 |
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EW 400; GLUCOPROTAMIN
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403-950-8
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164907-72-6
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Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B |
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203-856-5
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111-30-8
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Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A |
yes |
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200-240-8
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55-63-0
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Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2 |
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200-240-8
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55-63-0
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Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2 |
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203-474-9
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107-22-2
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Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
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206-058-5
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298-12-4
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Eye Dam. 1; Skin Sens. 1B |
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213-997-4
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1071-83-6
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Eye Dam. 1 |
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617-243-9
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81591-81-3
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Acute Tox. 4 |
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219-468-4
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2439-99-8
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Eye Dam. 1 |
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201-964-7
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90-05-1
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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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GUANIDINIUMBENZOAT
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429-820-0
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26739-54-8
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Acute Tox. 4 |
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200-002-3
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50-01-1
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Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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620-427-1
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108173-90-6
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Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 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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TILCOM HTB
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411-740-2
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22411-22-9
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Eye Dam. 1; Skin Sens. 1 |
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600-130-3
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100784-20-1
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Repr. 1B |
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HALOXYFOP ETHOXYETHYL EST
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402-560-5
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87237-48-7
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Acute Tox. 4 |
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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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12035-71-1
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Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1 |
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B Bacteria and similar species |
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218-165-4
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2058-94-8
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yes |
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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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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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200-962-3
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76-44-8
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Carc. 2; Acute Tox. 3; STOT RE 2 |
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213-831-0
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1024-57-3
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Carc. 2; Acute Tox. 3; STOT RE 2 |
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206-803-4
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376-06-7
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yes |
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203-767-1
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110-43-0
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Flam. Liq. 3; Acute Tox. 4 |
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203-388-1
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106-35-4
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Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2 |
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204-608-9
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123-19-3
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Flam. Liq. 3; Acute Tox. 4 |
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205-563-8
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142-82-5
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3 |
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203-838-7
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111-14-8
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Skin Corr. 1B |
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245-737-0
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23560-59-0
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Acute Tox. 3 |
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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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247-148-4
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25637-99-4
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Repr. 2; Lact. |
yes |
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204-129-5
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116-16-5
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Acute Tox. 4 |
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