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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Light oil (coal), coke-oven; Crude benzole [The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700 °C (1 292 °F)) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.]

The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents. EC / List no: 266-012-5 CAS no: 65996-78-3
EU CLP (1272/2008)
Carc. 1B; Muta. 1B