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).

3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate

LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50 EC / List no: 413-910-1 CAS no: 1467668-33-2
EU CLP (1272/2008)
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2