Procymidone chemical review

Nominated on the basis of concerns about toxicity (risk of reproductive and developmental effects), OHS (exposure and re-entry risks), and residues and trade (residue levels, MRLs and dietary exposure).

Prioritisation decision completed in September 2004.

Procymidone scoping document – 1 November 2004.

Work plan – Published on 1 July 2015

• s 32(1) notices were sent to holders of 16 products and 5 actives on 17 November 2004.
• s 32(2) notices were given to states and territories in November 2004.
• s 32(2) notices were published in the Gazette on 7 December 2004 (Submissions and data due 25 February 2005).
• s 159 letters for additional toxicology studies sent in 2005.
• Additional s 32 notices were sent to holders to include all approved actives and registered products in the review on the dates below:
  • 1 July 2015
  • 10 May 2016
  • 16 August 2017
  • 9 October 2017
  • 14 March 2018
  • 20 February 2019
  • 8 July 2021
• s 33 notices were sent to holders of active constituent approvals on 8 July 2021 to require data on the extent to which impurities of toxicological concern are present in the active constituent.
• s 33 notices were sent to holders of product registrations on 22 September 2021 to request data regarding sources of active constituent.
• s 33 notices were sent to holders of active constituent approvals on 9 March 2022 to request additional information regarding degradation of procymidone in the environment.

Human health risk assessment (including toxicology and OHS) Procymidone Human Health Risk (including Toxicology and Work Health and Safety) Assessment report (Published 30 October 2017).

The proposed regulatory decision (PRD) was published in an APVMA Special Gazette on 9 May 2022. Submissions on the proposed decision were invited until 9 August 2022.

The proposed regulatory decision (PRD) was published in an APVMA Special Gazette on 9 May 2022. Submissions on the proposed decision were invited until 9 August 2022. A copy of the published submissions (where consent to publish was provided) is available on our website.

The final regulatory decision was published in an APVMA Special Gazette on 11 October 2022. Labels for procymidone products have been varied as a result of the decision. Products bearing previously approved labels must not be supplied after 11 October 2024.

On 11 October 2022 the APVMA affirmed procymidone active constituent approvals and varied and affirmed procymidone product registrations and label approvals. 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 the previous label approval numbers must not be supplied after 11 October 2024.