Hazardous Substances Act (Act No. 15 Of 1973)

Within the Medicines Act, “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No. 15 of 1973) (hereinafter referred to as “the Hazardous Substances Act”).

The Hazardous Substances Act provides for the efficient, effective and ethical evaluation and registration of non-ionizing radiation emitting devices and radioactive nuclides. It also prohibits and controls the importation, manufacture, sale, use, operation, application, modification, disposal or dumping of substances and (electronic) products that may cause injury or death due to their detrimental direct or indirect effects. The Hazardous Substances Act classifies such substances and products in groups according to the risk associated with them.

A Group I, Group II, Group Ill or Group IV hazardous substance means a substance, mixture of substances, product or material declared in terms of section 2 (1) of the Hazardous Substances Act to be a Group I, Group II, Group III or Group IV hazardous substance, including:

• Any substance or mixture of substances which, in the course of customary or reasonable handling or use, including ingestion, might, by reason of its toxic, corrosive, irritant, strongly sensitising or flammable nature or because it generates pressure through decomposition, heat or other means, cause injury, ill-health or death to human beings, declared to be a Group I or a Group II hazardous substance;
  • Any electronic product, declared to be a Group III hazardous substance; and
  • Subject to the approval of the Minister of Mines, any radio-active material, declared to be a Group IV hazardous substance.