sec.112Making emerging risk declaration

sec.112 Making emerging risk declaration

The chief executive may make an emerging risk declaration in relation to a substance that is not a regulated substance if the chief executive believes— the substance is being made, sold or used in the State, including by using a device; and there is an urgent need to regulate, or further regulate, the substance under this Act because of a health risk. However, the chief executive may not make an emerging risk declaration in relation to a medical device under the Therapeutic Goods Act 1989 (Cwlth) . The emerging risk declaration may state particular conditions that apply to carrying out an activity with the substance, including conditions about using particular devices, if the chief executive is satisfied the conditions are reasonably necessary to prevent or minimise a health risk. (sec.112-ssec.1) The chief executive may make an emerging risk declaration in relation to a substance that is not a regulated substance if the chief executive believes— the substance is being made, sold or used in the State, including by using a device; and there is an urgent need to regulate, or further regulate, the substance under this Act because of a health risk. (sec.112-ssec.2) However, the chief executive may not make an emerging risk declaration in relation to a medical device under the Therapeutic Goods Act 1989 (Cwlth) . (sec.112-ssec.3) The emerging risk declaration may state particular conditions that apply to carrying out an activity with the substance, including conditions about using particular devices, if the chief executive is satisfied the conditions are reasonably necessary to prevent or minimise a health risk.

• (a) the substance is being made, sold or used in the State, including by using a device; and
• (b) there is an urgent need to regulate, or further regulate, the substance under this Act because of a health risk.