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).

Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate

EC / List no: 700-242-3 CAS no: 62037-80-3
EU REACH: List of SVHC
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)

HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)