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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EU REACH: List of SVHC
R Toxic for reproduction (article 57c)

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
Stannane, dioctyl-, bis(coco acyloxy) derivs. 293-901-5 91648-39-4 Expert judgement (ECHA)
dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. - - Expert judgement (ECHA)
Dioctyltin dilaurate 222-883-3 3648-18-8 Expert judgement (ECHA)