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).

Extract residues (coal tar), benzole fraction alk., acid ext.; Light Oil Extract Residues, low boiling [A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85 °C to 195°C (185°F to 383°F).]

A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85°C-195°C (185°F-383°F). EC / List no: 309-868-8 CAS no: 101316-63-6
EU CLP (1272/2008)
Carc. 1B; Muta. 1B