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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Sodium perfluoroheptanoate

EC / List no: 243-518-4 CAS no: 20109-59-5
EU REACH: List of SVHC
R Toxic for reproduction (article 57c)

PBT Persistent, Bioaccumulative and Toxic (article 57d)

VPVB very Persistent and very Bioaccumulative (article 57e)

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

E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)