Continuation of approvals and registrations

Fact Sheet No. 2

Australia currently has no requirement for existing agricultural and veterinary chemicals to be regularly reviewed. Australia only has an ad hoc reconsideration (chemical review) system whereby chemicals of concern are brought to the regulator’s attention by the community, by industry itself or on the regulator’s own initiative. This approach is not consistent with international best practice¹.

The Better Regulation of Agricultural and Veterinary Chemical reforms would implement a mandatory scheme where approval holders and registrants would apply for the continuation of active constituent approvals and product registrations on a regular basis². These applications would be assessed to ensure that active constituents and products do not pose unacceptable risks to human or environmental health. The scheme would be separate from, but complement the existing chemical review arrangements system and bring Australia into line with other countries which have similar schemes to ensure that agricultural and veterinary chemicals continue to meet community expectations.      

Scheme for continuation of approvals and registrations

The mandatory scheme for the continuation of approvals and registrations would be based on the principle that approval and registration should be continued where there are no reasonable grounds, founded in evidence, to doubt that the active constituent or product would not pose an unacceptable risk to human or environmental health. A diagram of the scheme is attached. The continuation of approvals and registrations scheme would promote public confidence in agricultural and veterinary chemicals while minimising impacts on industry.

To implement the scheme, existing approvals and registrations would expire on a set date. The APVMA would determine and notify approval holders and registrants of the expiry date within two years of the scheme commencing. The expiry date would be based on risk and take into account the APVMA’s published risk framework. Approval holders or registrants would need to apply to continue approvals and registrations (including listed registrations) before they expire. If an application is not received by the required date, approval or registration would not continue beyond the expiry date.

Applicants would provide information that confirms the particulars of the approval or registration. All information requested of applicants is information that would reasonably be expected to be held (or easily obtained) by the approval holder or registrant. It is not intended that the scheme will require the generation of data by applicants to support the continuation application. In addition, the applicants would declare their compliance with the obligations provided for in legislation, including the submission of new relevant information. The APVMA would assess these applications and consider information of relevance it has identified in relation to the active constituent or the chemical product.

Following assessment, the APVMA could continue approval or registration for a period of between seven and fifteen years. If necessary, approval or registration could be continued with amended conditions or particulars. Alternatively, the active constituent approval or chemical product registration could be referred for chemical review.