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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Naphtha (petroleum), light steam-cracked, hydrogenated; Low boiling point hydrogen treated naphtha [A complex combination of hydrocarbons produced from the separation and subsequent Hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately 50o C to 200o C (122 °F to 392 °F). The proportion of benzene hydrocarbons may vary up to 30 wt. % and the stream may also contain small amounts ofsulfur and oxygenated compounds.]

A complex combination of hydrocarbons produced from the separation and subsequent hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately 50°C to 200°C (122°F to 392°F). The proportion of benzene hydrocarbons may vary up to 30 wt. % and the stream may also contain small amounts of sulphur and oxygenated compounds. EC / List no: 296-942-7 CAS no: 93165-55-0
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1