Purpose:

This legislation establishes a comprehensive regulatory system in Australia for the evaluation, registration, and control of agricultural and veterinary chemical products and their active constituents.

Objectives:

• To evaluate, approve, and control the supply of active constituents for proposed or existing agricultural chemical products or veterinary chemical products.
• To evaluate, register, and control the manufacture and supply of agricultural chemical products and veterinary chemical products.
• To protect the health and safety of human beings, animals, and the environment.
• To ensure that the use of chemical products at the present time does not impair the prospects of future generations, supporting ecologically sustainable development.
• To further trade and commerce, and enhance the present and future economic viability and competitiveness of primary industry and the domestic manufacturing and formulating industry.
• To establish a regulatory system that is cost effective, efficient, predictable, adaptive, and responsive.
• To foster an open and accountable regulatory system that provides opportunities for public involvement and participation.
• To secure compliance through appropriate, proportionate, consistent, and effective compliance and enforcement measures.
• To achieve uniformity in the regulatory system for agricultural and veterinary chemical products throughout Australia.

Key Provisions:

• Product Approval and Registration: Establishes processes for the evaluation, approval, and registration of active constituents, chemical products, and their associated labels, based on criteria for safety, efficacy, trade, and labelling.
• Information Protection and Compensation: Details conditions and processes for the use of “protected information” provided to the APVMA, including provisions for compensation to the originator of such information when used for other applications.
• Control of Supply and Use: Imposes restrictions and prohibitions on the possession, custody, and supply of unapproved active constituents, unregistered or non-conforming chemical products, and products whose supply contravenes conditions or labelling requirements.
• Manufacturing Licensing: Requires persons involved in the manufacture of chemical products (other than prohibited or exempted products) to hold a licence, ensuring adherence to manufacturing principles and licence conditions.
• Investigative and Monitoring Powers: Grants the APVMA and its inspectors broad powers for monitoring compliance, investigating potential breaches (including search and seizure with or without warrants), and requiring information, documents, reports, and samples.
• Enforcement Framework: Provides a range of enforcement mechanisms, including civil penalty orders, infringement notices, enforceable undertakings, injunctions, substantiation notices for claims, and formal warnings to ensure adherence to the Code.
• Recall Authority: Authorises the APVMA to issue mandatory recall notices for chemical products that do not meet regulatory standards or pose risks, and mandates notification of voluntary recalls.

Evidence of Compliance Requirements For Agricultural Organisations:

• General Application Requirements (Section 8A):
  • Documentation/Action: Applications for approvals, registrations, variations, permits, or licences must be in writing, in the approved form, signed by the applicant, and lodged with the APVMA.
  • Documentation/Action: Applications must be accompanied by the prescribed fee.
  • Documentation/Action: Applications must include, or be accompanied by, all information specifically requested by the APVMA or prescribed by regulations for that application type.
  • Compliance Standard: The active constituent, chemical product, or label subject to the application must comply with all prescribed requirements.
  • Action: Any prior requirements by the APVMA under Section 157 (requiring samples for analysis) or Section 159 (requiring additional information, reports, or samples) related to the application must have been met.
  • Financial Requirement: All outstanding amounts (including taxes or penalties) due and payable by the applicant to the APVMA (under this Code or other agvet laws) must be paid.
• Notification of Incorrect Particulars or Conditions (Section 26):
  • Action/Reporting: Holders of approvals or registrations must provide written notice to the APVMA, signed by the holder, identifying any relevant particular or condition believed to be materially incorrect due to inaccurate recording, and stating the correct particular or condition.
  • Timeframe: This notice must be given within 28 days of the holder having reasonable cause to believe the inaccuracy exists.
  • Penalty: Failure to comply is an offence (strict liability, 30 penalty units) and a civil penalty provision.
• Notified Variations of Relevant Particulars (Division 2AA, Section 26AB):
  • Action/Documentation: Holders must lodge a written notice with the APVMA for notifiable variations of approval or registration particulars. The notice must be in the approved form, signed by the holder, accompanied by the prescribed fee, and contain all specified or prescribed information.
• Reconsideration Information Requirements (Sections 32, 33):
  • Action/Reporting: If the APVMA notifies a holder of an approval or registration that it is reconsidering it, the holder must provide any information of a stated kind or any relevant information known to the holder, and may make written submissions on the matters proposed for reconsideration.
  • Timeframe: Information and submissions must be provided within the period stated in the APVMA’s notice, which will be not earlier than 28 days after the notice is given.
  • Action/Reporting: The APVMA may require the holder to provide additional information, conduct a literature search and report results, perform trials/experiments and submit results, or provide samples for analysis by an approved analyst.
  • Timeframe: Compliance with these requirements must occur within a reasonable period stated in the notice (not exceeding periods prescribed by regulations for different information types).
  • Documentation: Information, reports, and results provided in response to these requirements must be in writing and signed by the holder (or attached to a covering letter signed by the holder).
  • Documentation/Samples: Samples must be labelled with a label signed by the holder or accompanied by a covering letter signed by the holder.
  • Penalty: Failure to comply with requirements under Section 32 or 33 is an offence (strict liability, 120 penalty units) and a civil penalty provision.
• Post-Suspension/Cancellation/End of Registration Supply (Sections 45C, 47E):
  • Action/Compliance: If an approval or registration is suspended, cancelled, or ends, and notice is given or published, any person with possession or custody of the constituent/product with the intention of supply must only deal with it in strict accordance with the instructions provided in the APVMA’s notice.
  • Penalty: Failure to comply is an offence (strict liability, 300 penalty units) and a civil penalty provision.
• Reserved Chemical Product Supply (Section 79B):
  • Action/Compliance: Supply of a reserved chemical product must be in accordance with the conditions specified in the regulations for reserved chemical products, unless authorised by a permit.
  • Penalty: Failure to comply is an offence (strict liability, 300 penalty units) and a civil penalty provision.
• Date-Controlled Chemical Product Manufacture/Import and Supply (Sections 90, 91):
  • Record-Keeping: Manufacturers or importers of date-controlled chemical products must make a record of the date of manufacture (or manufacture and import) and other prescribed particulars, in the approved form and prescribed manner.
  • Timeframe: Records must be made within 28 days of manufacture or import.
  • Record-Keeping: Records must be kept for at least the period prescribed by regulations.
  • Penalty: Failure to comply is an offence (strict liability, 120 penalty units) and a civil penalty provision.
  • Labelling: Supply of date-controlled chemical products requires an approved label showing manufacturing identification and the expiry date mandated by registration conditions.
  • Compliance: Supply of date-controlled chemical products after the stated expiry date is prohibited unless authorised by a permit or the supply date is demonstrably earlier than the product’s true required expiry date.
  • Penalty: Failure to comply with labelling or post-expiry supply rules is an offence (strict liability, 120 penalty units) and a civil penalty provision.
• Restricted Chemical Product Labelling (Section 95):
  • Labelling: Supply of a restricted chemical product requires the label to explicitly state “RESTRICTED CHEMICAL PRODUCT—ONLY TO BE SUPPLIED TO OR USED BY AN AUTHORISED PERSON”.
  • Penalty: Failure to comply is an offence (strict liability, 120 penalty units) and a civil penalty provision.
• Chemical Product Analysis Requirements (Section 99):
  • Action/Documentation: Persons who have/had/will have possession or custody of a substance intended for supply as a chemical product or active constituent, if required by the APVMA (for health/safety, environment, or trade), must provide specified information or documents concerning its constituents, concentration, formulation, composition, purity, manufacturers, addresses of manufacturing sites, packaging, labelling, and advertising material.
  • Action/Reporting/Sampling: These persons may also be required to arrange for analysis of the substance and provide the analysis results and the analyst’s certificate to the APVMA.
  • Measurement Standards: The notice may specify the manner of sample taking (e.g., under inspector supervision), analysis conduct (e.g., under approved analyst supervision, at a prescribed laboratory), timeframes for analysis, and that costs are borne by the person.
  • Documentation: Information and results provided must be in writing.
  • Penalty: Failure to comply with an APVMA notice under Section 99 is an offence (strict liability, 120 penalty units) and a civil penalty provision.
• Compliance with Recall Notices (Section 105):
  • Action/Compliance: Any person issued a recall notice by the APVMA must comply with all directions in the notice (e.g., stop supply, recover stocks, destroy/deal with product, report actions).
  • Penalty: Failure to comply is an offence (strict liability, 120 penalty units) and a civil penalty provision.
• Voluntary Recall Notification (Section 106):
  • Reporting/Documentation: A person voluntarily recalling a chemical product (due to safety/efficacy/labelling concerns or unregistered status) must give a written notice to the APVMA, in the approved form, containing all required information.
  • Timeframe: Notice must be given within 2 days after taking the recall action.
  • Penalty: Failure to comply is an offence (strict liability, 60 penalty units) and a civil penalty provision.
• Permit Conditions Compliance (Section 116):
  • Action/Compliance: Any person to whom a permit applies (including qualified employees or directors of a corporate holder) must not contravene a condition of the permit.
  • Penalty: Failure to comply is an offence (300 penalty units) and a civil penalty provision.
• Manufacturing Licence Conditions Compliance (Section 121):
  • Action/Compliance: A person who is the holder of a manufacturing licence must not contravene a condition of the licence unless authorised by a permit.
  • Penalty: Failure to comply is an offence (strict liability, 120 penalty units) and a civil penalty provision.
  • Inspection/Audit: Licence conditions include allowing an inspector to enter premises and exercise monitoring powers under Section 131A.
• Substantiation of Claims (Section 145G, 145GA, 145GB):
  • Action/Documentation: If the APVMA issues a written notice requiring substantiation of a claim or representation related to a chemical product, the person making the claim must provide information or documents capable of substantiating the claim, supply quantities, place, or period, or other specified information/documents.
  • Timeframe: Compliance required within 21 days after the notice is given, or any further time allowed by the APVMA.
  • Penalty: Failure to comply is an offence (50 penalty units) and a civil penalty provision.
• Enforceable Directions Compliance (Section 145H):
  • Action/Compliance: A person issued a written direction by the APVMA to take steps to comply with the Code (where non-compliance is believed and it’s necessary for health/safety, environment, or trade) must comply with the directions.
  • Timeframe: Compliance must be within the reasonable time specified in the notice.
  • Penalty: Failure to comply is an offence (30 penalty units, or 120 penalty units for an aggravated offence) and a civil penalty provision.
• Notification of New Information (Sections 160A, 161):
  • Reporting: Applicants for approvals/registrations/permits/licences/variations must, as soon as they become aware, give the APVMA any relevant information (contradicting previous info or showing AC/CP/label may not meet criteria) while the application is pending.
  • Reporting: Holders of approvals/registrations/permits must, as soon as they become aware, give the APVMA any relevant information (contradicting existing records or showing AC/CP/label may not meet criteria).
  • Documentation: All such information must be given in writing, signed by the applicant or holder.
  • Penalty: Failure to comply with either Section 160A or 161 is an offence (300 penalty units) and a civil penalty provision.

Metadata Keywords:

Australian legislation, agricultural chemicals, veterinary chemicals, APVMA, chemical product regulation, compliance, permits, licences, enforcement, recalls.

Publication Information:

Compilation date: 14 October 2024 Compilation No. 34

Agricultural Industry Alignment:

Beef & Veal, Chicken, Coarse Grains, Cotton, Dairy, Eggs, Fisheries, Forestry, Horticulture, Oilseeds, Pig, Sheep Meat, Sugar, Wheat, Wine, Wool.

Date Added to database:

This document was parsed and added to the database on 25-07-2025

URL:

https://www.legislation.gov.au/C2004A04723/2024-10-14/2024-10-14/text/original/pdf →