Pesticides Regulatory Newsletter, March 2025

1. Pesticide Directors’ update: Dr Gary Dorr and Dr Beena Anil Biswas

Welcome to the March 2025 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Pesticides Regulatory Newsletter.

In this edition we have included information on a range of regulatory topics and advice for applicants on the tools available for searching registered chemical products and permits. We have also included advice regarding information lists, variation to labels, consolidation and deconsolidation of Minor Use and Export Permits, and scheduling of agricultural chemical products.

We would also like to inform stakeholders of a staffing update in the Director of Pesticides role. Mr Hugh Dawick has transitioned to a part-time role as Director of Projects (Pesticides). Dr Beena Anil Biswas will be acting in his former position as Director of Pesticides until 30 April 2025. Recruitment for a permanent EL2 Director of Pesticides will commence shortly. If you would like to stay updated regarding this recruitment, as well as other career opportunities at the APVMA, please visit our careers page, or follow us on LinkedIn.

If you have any suggestions or requests for future editions of the APVMA’s Pesticides Regulatory Newsletter, please send them through to communications@apvma.gov.au.

2. New product registrations

The APVMA publishes a fortnightly Gazette, which includes information about new product registrations and variations to currently registered particulars or conditions for registration.

Table 1 below lists the new registration of an agricultural chemical product, based on a new active constituent, published in the Gazette to date for FY 2024–25 and not included in previous newsletters.

Table 1: New registration of an agricultural chemical product based on a new active constituent

Registration of agricultural chemicals products based on new active constituents requires consultation prior to registration. Please see the public consultation section on our website for current consultations.

3. Useful information for industry

This edition’s useful information for industry covers:

• searching registered chemical products and permits
• information lists
• variation to labels
• consolidation and deconsolidation of Minor Use and Export Permits
• scheduling of Agricultural chemical products.

3.1. Searching registered chemical products and permits

The APVMA has created a Boolean search quick reference guide for use on the Public Chemical Registration Information System Search (PubCRIS) and the Agricultural and Veterinary Permits Search. Please refer to the website for more information.

3.2. Information lists

The APVMA has received an increase in information lists (data lists) that do not meet the legislative requirements for both registration and variation applications. It is your responsibility to ensure the information entered into an information list is accurate. During any phase of the application assessment (including at preliminary assessment and before your application can be finalised), the APVMA may request you provide an amended information list either under r8AHAA or by issuing a section 159 notice. Please adhere to the requirements outlined below for submission of information lists to avoid unnecessary delays.

3.2.1. Background

An information list is a list containing details about the information submitted with an application to meet administrative requirements and address the safety, efficacy, and trade criteria. The Agvet Code requires us to publish this information, along with a summary of the application, after the application passes preliminary assessment. The information list is also necessary for any relevant limitations on use (data protection) to be appropriately administered. For each item of information relied on by the APVMA in making its decision, the application information details must also be published and can be viewed in the PubCRIS database. 

3.2.2. Guideline

To help you prepare an information list correctly, we have prepared a guideline which can be found on our website at: https://www.apvma.gov.au/registrations-and-permits/chemical-product-registration/what-to-include/info-lists.

3.2.3. Legislation

The Agricultural and Veterinary Chemicals Code Regulations 1995, includes the definition for ‘application information details’ (the information list) as:

For an item of information contained in or accompanying an application, means the following details:

1. the title shown on the item of information;
2. the name of the author, or each of the authors, of the information; 
3. the date shown on the item of information (if any);
4. if no date is shown on the item of information – the date when the preparation of the information was completed;
5. if the information was published;
6. the date when it was published; and
7. the name of the publication in which it was published;
8. a unique identifier for the item of information that indicates the location of the item in the application;
9. the name and address of the authorising party for the information.

3.2.4. Consolidation of information

The following types of information may be combined into a single document with a single entry in the information list:

1. Safety data sheets (SDS) for excipients (non-active constituents)
2. Certificate of analysis for excipients (non-active constituents)
3. Consent letters (limits on use/confidential commercial information)

If you choose to consolidate the above type of information, a cover page and index (table of contents) is required. The document must be named appropriately. For example, SDS for excipients (non-active constituents)’ or ‘Certificate of analysis for excipients (non-active constituents)’.

If you choose to submit safety data sheets for excipients (non-active constituents) individually instead of a consolidated document, we recommend describing the entry in such a way that you do not disclose the excipient name, for example, ‘SDS for non-active constituent 1’ would be acceptable, using a different number for each excipient. 

Consolidating studies such as multiple efficacy and crop safety reports into one document with one entry on the information list is not allowed. These must be split into separate documents for each study, and a separate entry for each individual study on the information list.

3.2.5. Titles

The title of the document should be entered as it appears on the respective report/document. Generalising titles with a code instead of the correct title is not acceptable. For example, using ‘Efficacy Code 1234ZXY’ when the correct title is ‘Efficacy of glyphosate in fallow situations’.

3.2.6. Author

A major issue with information lists presently, is the listing of ‘Anon’ as the author of a data item. When the author is identified in the data and known on the study, it is not appropriate to enter ‘Anon’ as the author. The author is usually the person or persons responsible for the production of the information. 

3.2.7. Authorising party

Generally, the authorising parties on the information list follow the legislative criteria. The Agvet Code defines the authorising party of information as 'a person who would be entitled to bring an action for breach of an obligation of confidence if the information were disclosed by someone else to the APVMA for the purposes of this Code without the person’s permission.' It is also used to identify who can grant consent for the disclosure or use of the information if applicable.

3.2.8. Cover sheets

The use of a cover sheet at the beginning of a data item to serve as a record for the information list is not appropriate. For example, if a specific piece of data already contains a relevant title, author and date of study, it is not necessary to add a cover sheet to this data with your company name and date of submission (e.g. ‘APVMA Submission, July 2025, Author: applicant’, where the correct description of the data would be ‘Toxicological profile for glyphosate 255 g/L suspension concentrate products, August 2001, Author: J. Bloggs’. It is an offence under the Agvet Code to provide false or misleading information to the APVMA.

3.3. Variation to labels

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the legislative criteria for variation applications to registered chemical products and approved labels. Item 31(2) states: The information must be presented in a way that shows how the variation affects the information (for example, all additions and deletions must be clearly identified). One way this can be achieved is to submit a marked-up label with the application that clearly shows any changes to the currently approved label. 

For situations where there are multiple reference products, it can be helpful to colour code the changes on the label to indicate the appropriate reference product to support each variation. This can also be beneficial for new product registrations where different uses on the label may be sourced from multiple reference products. Failure to clearly identify the changes may result in a notice being issued to request clarification of the variations being requested, or the application being refused as it does not meet the application requirements.

3.4. Consolidation and deconsolidation of Minor Use and Export Permits

The APVMA is moving away from large, consolidated permits, many of which have become difficult to process and follow over time. It takes a lot of APVMA resources to re-evaluate a permit of such size under one application, and it can become difficult to ensure we are satisfied of the risk criteria for multiple products/actives and use patterns as contemporary risk assessments have changed over time. Lack of clarity for users of the permits has also become an issue as the permit may become hard to understand and follow over time potentially leading to incorrect use. 

Applicants seeking renewal of large, consolidated permits are advised to apply for new permits to deconsolidate uses into multiple, separate permits. If you are a holder of a large permit that is due for renewal, you are invited to discuss deconsolidation with the Permits Team. Please contact enquiries@apvma.gov.au.

3.4.1. Minor use permits

Under a minor use permit, products with similar use patterns may be consolidated into a single permit for ease-of-use. The APVMA generally considers up to 5 active constituents/products consolidated into one permit as acceptable. Uses proposed for different categories should be under separate permits. For example: herbicides, fungicides, and insecticides. 

Minor use permits for veterinary use are often not suitable for consolidation, however there are some examples where it occurs (for example, under certain circumstances existing autogenous vaccines may be combined into a master permit).

Applications for consolidated minor use permits will be considered for use patterns being renewed under a current permit only. In general, new permits should be limited to one product/active and come in under an item 21. There are reasonable exceptions to this (for example, where 2 products should be used together as part of a resistance management program or where uses are very similar). 

Please note that this is provided as guidance only, there may be circumstances where an applicant may propose to have a greater number of uses under one permit. Applications for consolidated permits, and their appropriateness to be included under a single permit, will be considered on a case-by-case basis according to the level of risk assessment required.

3.4.2. Export permits

For export permits, the APVMA generally considers up to 20 active constituents/products consolidated into one permit as acceptable. These products should generally be grouped in a constructive manner with similar actives, reason for export, or use patterns. 

Products or actives that are not already contained on a current export permit, should come in under a new item 19 application and may be consolidated into another existing export permit upon renewal, if the total number of products or actives on a single export permit is no greater than 20. 

Please note that this is provided as guidance only, applications for consolidated export permits, and their appropriateness to be included under a single permit, will be considered on a case-by-case basis.

3.5. Scheduling of agricultural chemical products

The APVMA has identified a number of agricultural products where the scheduling associated with an active or excipient has changed, and product labels must be updated to reflect the change. If you identify that the scheduling or constituent statements are incorrect, please contact us to discuss the appropriate path to updating your label.

3.5.1. Background

Before a chemical substance can be used in Australia, the substance must be reviewed by the scheduling secretariat, if considered necessary, the substance is listed in the Schedules of the Australian Poisons Standard. The Poisons Standard contains 9 Schedules (Schedules 5, 6 and 7 are relevant to agricultural products) and appendices A to M (appendix B is relevant to agricultural products).

Appendix B lists substances which have been considered and deemed not to require control by scheduling. Schedules 5, 6 and 7 correspond to substances which must be labelled with signal headings ‘Caution’, ‘Poison’ and ‘Dangerous Poison’ respectively to reflect potential hazard.

It is a requirement of both APVMA legislation and the Australian Poisons Standard, that the correct signal heading be displayed on products registered with the APVMA. The signal heading may be required as the result of either the active ingredient or excipient present in the formulation at a stated concentration. In addition to the signal heading, the name and quantity of any scheduled substance must also be listed as part of the constituent statement on a product label. 

The following excipients and actives have been identified as affecting a number of products. Please check your products and ensure they align with the current Poisons Standard entry if they contain these actives or excipients. If you identify that the Scheduling or constituent statements are incorrect, please contact us to discuss the appropriate path to updating your label.

Actives

• 340 g/L MCPA + 80 g/L Dicamba – some products incorrectly classified as Schedule 6 but should be Schedule 5.
• Granular calcium chloride – Listed under chlorinating compounds. Scheduling depends on concentration.

Excipients

• Ethylene Glycol – Listed in Schedule 5 or 6 dependent on concentration and presence of bittering agent.
• Polyethanoxy (15) tallow amine – Schedule 5.
• N,N – dimethyloctanamide and N, N – dimethyldecanamide – Listed in Schedule 6 with no cut-off.
• Diethylene glycol monobutyl ether – Schedule 5 if present above 10%.
• Tetrahydrofurfuryl alcohol – Schedule 6.