Malathion chemical review

In progress

Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.

Work plan

Work plan

Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.

Chemicals

  • Malathion

Review period

Timeframe calculation pursuant to Regulation 85 of the Agricultural and Veterinary Chemicals Code Regulations 1995
A + B + 2E + 3C + J + D + X = 31 months

A = 9 months (Toxicology – level 3*)
B = 6 months (Chemistry – level 3; OH&S – level 3*)
C = 3 months (Finalisation – type 1)
D = 4 months
E = 0 months
J = 3 months (consultation with jurisdictional coordinator)
X = 0 months (in any other case)

*pre-December 2022 module descriptions
1. Nomination

1. Nomination

Phase status

Completed

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.

2. Prioritisation

2. Prioritisation

Phase status

Completed

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

3. Scoping and work plan

3. Scoping and work plan

Phase status

Completed

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.

4. Notice of reconsideration

4. Notice of reconsideration

Phase status

Completed

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

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 of product registrations on 28 July 2022 to request data regarding the impurities in active constituents.

5. Assessment

5. Assessment

Phase status

Completed

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.

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

When all the component risk assessments have been completed, the proposed regulatory decisions will be drafted.

6. Proposed regulatory decision

6. Proposed regulatory decision

Phase status

Completed

The proposed regulatory decision (PRD) was published in an APVMA Special Gazette on 22 November 2022. Submissions on the proposed decision are invited until 23 February 2023 (see the Gazette for instructions on making a submission).

7. Consultation

7. Consultation

Phase status

Completed

The proposed regulatory decision (PRD) was published in an APVMA Special Gazette on 22 November 2022. Submissions on the proposed decision are invited until 23 February 2023. Details on how to make a submission are included in the Special Gazette.

8. Final regulatory decision

8. Final regulatory decision

Phase status

Forecasted

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.

Following the close of the public consultation period on the proposed regulatory decision and consideration of submissions received, the final regulatory decision will be published.

Publication of the final regulatory decision is expected in November 2023.

9. Implementation

9. Implementation

Phase status

Forecasted

The implementation period will begin on the date the final regulatory decision is made.

Publication archive

Publication Archive

Type Title Publication date
Gazette Special Gazette 22 November 2022
Report Malathion Review Technical Report 22 November 2022
Report Maldison chemistry report 12 April 2016
Report Maldison review scope document 1 February 2003
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