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 oils (coal), coal tar-residual pyrolysis oils, naphthalene oils; Redistillates [A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225o C to 255o C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons.]

A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225°C to 255°C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons. EC / List no: 310-170-0 CAS no: 122070-79-5
EU CLP (1272/2008)
Carc. 1B; Muta. 1B