A recall refers to the action stated in a notice given to the notified person or the action taken voluntarily by a product holder to prevent or reduce any harmful effects associated with the use of an agricultural or veterinary chemical product (or batch).
The recall of an agricultural or veterinary (agvet) chemical product may be initiated for several reasons. The product may be identified as not meeting the criteria for safety, efficacy, trade or labelling criteria as per sections 5A, 5B, 5C and 5D of the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code). Part 6 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) contains the provisions relevant for the recall of agvet chemical products.
Recalls most commonly occur due to a manufacturing quality issue or other concerns related to specific batches of a product. A recall may also be required when new information concerning the product or its active constituent/s becomes available. Examples of this may include:
- out-of-specification results for batches of an agvet chemical product or active constituent
- product defects which may have implications on safety or efficacy
- other relevant information regarding manufacture, supply or use of the constituent or product such as product complaints, adverse experience reports or as a result of residues monitoring.
Roles and responsibilities
The Australian Pesticides and Veterinary Medicines Authority (APVMA) shares responsibility for the recalls process with the product holder (the individual or company who holds the registration for the product, also referred to as ‘the holder’ and defined under Part 1, section 3 of the Agvet Code).
The product holder
Product holders work with the APVMA to protect users from adverse experiences from the use of APVMA-registered agvet chemicals. If you are a supplier of an agvet chemical product and have become aware of information that suggests you may need to recall the product, you should contact the APVMA as soon as possible. Please direct any information or questions to recalls@apvma.gov.au.
Under section 106 (1) of the Agvet Code, if a person voluntarily takes action to recall a chemical product, the person must, within 2 days after taking action, give the APVMA written notice using the approved form. It is an offence not to do so.
The responsibilities of the product holder may include but are not limited to:
- stopping supply of a product (registered or unregistered)
- notifying the relevant persons in the supply chain of the product such as wholesalers, retainers, end-users or veterinarians of the recall
- taking active steps to locate, retrieve and correct or destroy an agvet chemical product within a distribution network
- reporting on the details of the recall notice such as the product details, where it is sold, when it was sold, reasons for recall, hazard associated with the use of affected product, and what to do if someone has possession of the affected product
- Investigating the root cause of the issue and taking corrective actions to prevent it happening again
- keeping a record of all the actions taken during the recall, including how many units of the affected product were sold and how many returned. The APVMA may wish to audit the recall or exercise its monitoring powers to examine relevant records.
Section 161 of the Agvet Code also imposes reporting obligations for relevant information (defined under s161(2) of the Agvet Code) on holders of active constituent approvals, registrations, permits, and label approvals. More information about this requirement can be found on the APVMA website.
More information for product holders and/or manufacturers regarding the recall process can be found in the APVMA's recall guidelines.
It is an offence to supply or sell unregistered agvet chemical products. Should products that are not registered with APVMA (or authorised under permit) enter the market, they must be recalled. If the concentration, composition, or purity of constituents of a certain batch of a registered product varies by more than the prescribed extent set out in the Register of Chemical Products with the APVMA, it may be considered unregistered.
The APVMA
As the regulator responsible for the recall of agvet chemical products that have been supplied to the Australian market, the APVMA must publish the notice of voluntary recall on the APVMA website within 3 days of notification by the product holder and in the APVMA Gazette within 14 days.
This requirement does not apply if the affected product was not supplied to a premises where a person could have purchased the product and it was not supplied to a user of the product.
The APVMA also assesses the risks around the recall and advises the product holder on their responsibilities in recalling a product.
If an agreement cannot be reached, the APVMA may initiate a compulsory recall under sections 101 to 103 of the Agvet Code. In this event, the APVMA will direct the way the recall is to occur and enforce compliance.
A listing of agvet chemical recalls is available on the APVMA website.