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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Distillates (coal tar), pitch, pyrene fraction; Heavy Anthracene Oil Redistillate [The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380 °C to 410 °C (7160 to 770 °F). Composed primarily of tri-and polynuclear aromatic hydrocarbons and heterocyclic compounds.]

The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380°C to 410°C (716°F to 770°F). Composed primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic compounds. EC / List no: 295-313-4 CAS no: 91995-52-7
EU CLP (1272/2008)
Carc. 1B