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).

RELEVANT LEGISLATION
Back to the List

lead sulfochromate yellow; C.I. Pigment Yellow 34 [This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.]

This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603. EC / List no: 215-693-7 CAS no: 1344-37-2
EU CLP (1272/2008)
Carc. 1B; Repr. 1A; STOT RE 2
EU REACH: List of SVHC
C Carcinogenic (article 57a)

R Toxic for reproduction (article 57c)