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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 January 2022. Database contains 4812 unique substances/entries.
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Skin Sens. 1
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Skin Irrit. 2
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135821-03-3
yes
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135821-74-8
yes
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75166-31-3
yes
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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75166-30-2
yes
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178961-20-1
Skin Sens. 1
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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Acute Tox. 4; Skin Sens. 1
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99095-19-9
Acute Tox. 4; Skin Sens. 1
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4482-55-7
Skin Irrit. 2
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6202-15-9
Expl. 1.1; Acute Tox. 4
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540-73-8
Carc. 1B; Acute Tox. 3
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yes
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5836-73-7
Acute Tox. 2
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Skin Irrit. 2
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7076-53-1
Acute Tox. 3
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240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
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1065124-65-3
Acute Tox. 4; STOT SE 2
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130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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21436-97-5
Carc. 1B; Acute Tox. 3
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161973-12-2
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
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STOT RE 2; Eye Dam. 1; Skin Sens. 1
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72319-19-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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yes
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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15271-41-7
Acute Tox. 2; Acute Tox. 3
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2532-43-6
Acute Tox. 3
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Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
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Carc. 1B; Acute Tox. 4
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Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
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yes
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2315-61-9
yes
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521947-27-3
yes
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yes
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186825-39-8
yes
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yes
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yes
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yes
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51-14-9
Acute Tox. 4
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yes
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yes
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yes
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Self-react. C; Carc. 2
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Eye Dam. 1
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10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
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118725-24-9
Eye Dam. 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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