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Australia - Regulation

The Industrial Chemicals Act 2019 established the Australian Industrial Chemicals Introduction Scheme (AICIS) to regulate the importation and manufacture (introduction) of industrial chemicals in Australia. 

AICIS replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020. The AICIS regulates chemicals (including polymers) introduced for an industrial use, such as in inks, paints, adhesives, solvents, cosmetics and personal care products, cleaning products, as well as in manufacturing, construction, and mining applications and to promote the safe use of industrial chemicals in order to protect human health and the environment.

Importers and manufacturers (introducers) of industrial chemicals for commercial purposes need to register their business under this scheme. All industrial chemical introducers must categorise their chemical importation or manufacture (introduction) into the following categories i.e., Listed introduction, exempted introduction, reported introduction, assessed introduction, commercial evaluation before placing into Australian territory.

If the introduction is listed in the Australian Inventory of Industrial Chemicals (the Inventory), then it is categorized as Listed introduction, and can be placed in the market in complying with the regulatory obligations (if any). If the introduction is not in the listed category, then it must be authorized into any one of the other categories.

 

Annual Declaration

Regardless of the introduction category, one must submit an annual declaration between August 1 and November 30 each year. This declaration is to make about the industrial chemicals imported or manufactured in the previous registration year and confirms that introductions were authorized under Australian laws.

The Australian Pesticides and Veterinary Medicines Authority is responsible for the registration, approval, and restriction of agrochemicals sold in Australia (APVMA). The use of pesticides is regulated by the Environmental Protection Agency (EPA) under the Pesticides Act of 1999 and Regulation 2017. The EPA, Commonwealth and NSW government agencies, as well as other stakeholder organisations, oversee pesticide management to guarantee no harm to human health or the environment. 

Authorties 

APVMA administers Australia’s agvet legislation and has a duty to not only manage potential risks, but also enforce compliance when required. 

The legislation includes: 

  • the Agricultural and Veterinary Chemicals Act 1994 (the Agvet Act) 

  • Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) 

  • the Agricultural and Veterinary Chemicals (Administration) Act 1992 (the Admin Act) 

  • the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 (the Collection Act). 

 

APVMA has the following duties:  

  • issue substantiation notices 

  • issue formal warnings 

  • enter enforceable undertakings 

  • issue enforceable directions 

  • issue infringement notices 

  • issue stop supply and recall notices 

  • cancel or suspend permits for noncompliance or prior convictions 

  • cancel or suspend permits to prevent imminent risk 

  • issue a notice to attend, give information, or produce documents or things 

  • obtain and execute monitoring warrants 

  • obtain and execute investigation warrants. 

 Companies involved in the manufacturing, formulation, repackaging, exportation, importation, marketing, and application service of pesticides in Australia shall file the registration application 

Agricultural and Veterinary Chemicals (Administration) Act 1992

The APVMA is established as an independent Commonwealth statutory authority responsible for the regulation and management of agricultural and veterinary chemicals in Australia up to the point of retail sale under this Act. This Act provides all of the internal details of the APVMA's establishment, as well as its functions and powers. It also includes laws governing chemical import and export, as well as enforcement and inspections. 

Agricultural and Veterinary Chemicals Act 1994

This act provides the constitutional and other legal elements necessary for the Agvet Code's implementation. The Agvet Code is to be applied as a law of the participating areas, according to the agreement. The Australian Capital Territory and any other territory designated as a participating territory by Regulations in force under section 25 of the act are considered participating territories. 

Agricultural and Veterinary Chemicals Code Act 1994

The Agvet Code is included as a schedule in this Act. The Agvet Code provides extensive rules that enable the APVMA to analyze, authorize, register, and review active ingredients and agricultural and veterinary chemical products (and their accompanying labels), as well as give permits and licenses for chemical product manufacturing. It also includes regulations to manage the supply of chemical products, as well as provisions to ensure that the Agvet Code is followed and enforced. 

The National Registration Authority for Agricultural and Veterinary Chemicals (NRA) later became the APVMA. The AGVET Code is used by the APVMA of the participating states and territories for addressing the registration process of the active ingredients or chemicals.  

In July 1991, the Commonwealth, states and territories agreed for establishing the National Registration Scheme (NRS) for agricultural and veterinary chemicals. The development of the NRS contributes to the process of assessment and registration of all AGVET chemical products which was independently undertaken by the commonwealth states and territories.  

The APVMA partners between the Commonwealth and the states and territories within which the establishment of NRA and APVMA took place as a Commonwealth statutory authority, that is responsible for the evaluation, registration and review of agricultural and veterinary chemicals and their control.  

The APVMA is also termed as an independent statutory authority that implements the legislative powers, functions and AGVET Codes. 

The product label is the primary and most effective means of communicating to users' critical information about pesticide and veterinary drug use that is both safe and effective. Current pesticide and veterinary medicine labelling, on the other hand, is complex, confusing, and inflexible, with separate labelling codes and information for different statutory needs. Because labels have become more extensive and comprehensive, vital information can be difficult to locate. Furthermore, updating information on labels takes time, which can result in different labels for the same product along the supply chain. 

By focusing pre-market regulatory effort on those label features that are unique to pesticides and veterinary pharmaceuticals, the Panel advises simplifying labelling and expediting label evaluation. Content that does not require assessment would be subject to the label.

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