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), heavy oils, pyrene fraction; Heavy Anthracene Oil Redistillate [The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350 °C to 400 °C (662 °F to 752 °F). Consists predominantly of tri-and polynuclear aromatics and heterocyclic hydrocarbons.]

The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons. EC / List no: 295-304-5 CAS no: 91995-42-5
EU CLP (1272/2008)
Carc. 1B