EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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
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EU CLP (1272/2008)
Carc. 1A; Acute Tox. 4; Skin Sens. 1

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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
Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Expert judgement
Potassium hydroxyoctaoxodizincatedichromate(1-) 234-329-8 11103-86-9 Expert judgement
Zinc chromate 236-878-9 13530-65-9 Official source
Zinc dichromate 237-843-0 14018-95-2 Expert judgement
Chromic acid, potassium zinc salt 255-252-6 41189-36-0 Expert judgement
C.I. Pigment Yellow 36 609-398-6 37300-23-5 Expert judgement