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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Tar acids, distn. residues; Distillate Phenols [A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60 °C to 80 °C (140°F to 176°F).]

A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60°C to 80°C (140°F to 176°F). EC / List no: 306-251-5 CAS no: 96690-55-0
EU CLP (1272/2008)
Carc. 1B; Muta. 1B