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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Phenols, ammonia liquor ext.; Alkaline Extract [The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700 °C (1292°F)) destructive distillation of coal. It consists predominantly of a reaction mass of monohydric and dihydric phenols.]

The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C (1292°F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols. EC / List no: 284-881-9 CAS no: 84988-93-2
EU CLP (1272/2008)
Carc. 1B; Muta. 1B