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).

tris(tetramethylammonium) 5-hydroxy-1-(4-sulphonatophenyl)-4-(4-sulphonatophenylazo)pyrazole-3-carboxylate

LEXMARK YELLOW DYE 415; PRISM YELLOW EC / List no: 406-073-9 CAS no: 131013-81-5
EU CLP (1272/2008)
Acute Tox. 3