Malathion chemical review

Malathion (maldison) active constituents, chemical products and labels were nominated for review in response to an invitation to the public by the APVMA (then the NRA) on 1 November 1994. Eighty of the nominated chemicals, including malathion, were included in the priority candidate review list published in the Gazette on 2 May 1995.

Malathion was prioritised for review in 2003 due to public health and OHS concerns (including potential for toxic impurities).

The scope of the review includes reconsideration of malathion active constituents, chemical products and labels through assessments related to chemistry and human health, including work health and safety.

The review scope document (2003) is available in the publication archive tab.

The work plan was first published on 1 July 2015.

s 32 notices were sent to holders on 27 February 2003 (submissions due 3 June 2003). 

The notice of reconsideration was published in the Gazette on 4 March 2003. 

The s 32 notice of reconsideration was given to holders and chemical coordinators of the states and territories upon commencement of the review in 2003. 

Additional s 32 notices were sent to holders in December 2013 and July 2015 to include all approved actives and registered products in the review. 

s 32 notices were sent to holders of product registrations on 12 April 2022. 

s 32 notices were sent to holders of product registrations on 3 May 2022.

S 33 notices were sent to holders on 18 August 2003 to request storage stability data.

S 34P notices proposing to suspend product registrations and label approvals were issued to some holders on 4 August 2004.

Additional s 33 notices were sent to some holders on 11 December 2013 to request storage stability data.

S 34P notices proposing to suspend product registrations and label approvals were issued to some holders on 18 December 2014.

Additional s 33 notices were sent to some holders on 18 December 2015 to request storage stability data.

In April 2016 the APVMA published the maldison chemistry report.

Additional s 33 notices were sent to some holders on 9 June 2016 to request storage stability data.

Additional s 33 notices were sent to some holders on 4 February 2022 to request chemistry data.

s 33 notices were sent to holders of product registrations on 23 March 2022 to request data in regarding residues. 

s 33 notices were sent to holders of product registrations on 28 July 2022 to request data regarding the impurities in active constituents. 

The APVMA published the draft malathion Review Technical Report in November 2022. 

The APVMA published the final malathion Review Technical Report in May 2024.

The proposed regulatory decision (PRD) was published in an APVMA Special Gazette on 22 November 2022. Submissions on the proposed decision were invited until 23 February 2023.

The proposed regulatory decision (PRD) was published in an APVMA Special Gazette on 22 November 2022. Submissions on the proposed decision were invited until 23 February 2023. A copy of the published submissions (where consent to publish was provided) is available on the APVMA website.

A decision was made to suspend the registration of certain products containing malathion in 2004, because of a failure to provide data relating to impurities and storage stability of these products. Holders were notified of the proposed suspension of the registration of certain products containing malathion on 4 August 2004 and later notified of the decision to suspend on 24 September 2004. A permit was issued under s 114 of the Agvet Code. The notice was published in the Gazette of 5 October 2004. Product registration suspensions were revoked upon the provision of the required data.

The final regulatory decision was published in an APVMA Special Gazette on 2 May 2024. Labels for products containing malathion as an active constituent have been varied as a result of the decision. Products bearing previously approved labels must not be supplied after 1 May 2026.

On 2 May 2024 the APVMA varied and affirmed malathion approvals and registrations. Labels for products containing malathion as an active constituent have been varied as a result of the decision. The APVMA has determined that products bearing previous labels may continue to be supplied for 2 years from the date of the final regulatory decision, under section 81(3) of the Agvet Code. 

Products bearing previously approved labels must not be supplied after 1 May 2026.