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).

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Anthracene oil; Anthracene oil [A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300 °C to 400 °C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole.]

A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole EC / List no: 292-602-7 CAS no: 90640-80-5
EU CLP (1272/2008)
Carc. 1B
EU REACH: List of SVHC
C Carcinogenic (article 57a)

PBT Persistent, Bioaccumulative and Toxic (article 57d)

VPVB very Persistent and very Bioaccumulative (article 57e)