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Australia’s new industrial chemical regulations There have been changes to Australia’s industrial chemical regulations. These changes include more monitoring and evaluation of products. Laura Whiteman and Lily Hou explain. On 1 July 2020, Australia’s Industrial chemical regulations were changed. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) will be replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS). Industrial chemicals in Australia are regulated by exclusion, meaning that a chemical is an industrial chemical if it is not for therapeutic use, agricultural or veterinary use, or a food. Anyone who imports or manufactures industrial chemicals in Australia must: 1. 2. 3. 4. 5.
Register their business with AICIS and pay a fee. Categorise the import or manufacture of each chemical. Submit declarations and reports. Keep records for a minimum of five years. Provide information to AICIS if requested.
The new scheme will focus primarily on higher risk introductions and will have a greater use of international assessments. The use of animal test data for cosmetic ingredients will be restricted, and more monitoring and evaluation of products will be undertaken. The new Industrial Chemical Act (ICA) requires introducers of industrial chemicals to categorise their introduction into one of five main categories: listed, exempted, reported, assessed, and commercial evaluation. It’s important to note that it will be an offence to not know what you’re introducing, or not having access to the required information from a supplier. If you are not aware of all of the required information, you will need to contact your supplier to help you categorise your introduction. Australia maintains a list of industrial chemicals that can be introduced or manufactured in Australia. This list is changing from the Australian Inventory of Chemical Substances (AICS) to the Australian Inventory of Industrial Chemicals (AICIS Inventory). This new inventory is solely for industrial chemicals, and approximately 1600 chemicals in the AICS will be removed from the inventory as they were not industrial chemicals. This new inventory will assist in protecting confidential business information (CBI) by using substitute terms, AICIS Approved Chemical Names (AACN) and Generalised End Use (GEU), where relevant. Where applicable, the new inventory will also include a defined scope of assessment, any conditions of introduction or use, and specific information requirements. For a “Listed” introduction, it will be important for manufacturers to ensure that they meet all the conditions associated with it on the AICIS inventory. This can include the volume permitted to be introduced or used, and where or how the chemical is allowed to be used. For a chemical not listed on the Australia Inventory, unless you introduce it for commercial testing in Australia, you will need further evaluation. It might have protected CBI which AICIS can determine by searching through the listings which might have AACNs or confidential terms. Genuine enquirers of these chemicals then gain rights to be notified and make applications under CBI protection. If the chemical is not on the inventory at all, then the importer or manufacturer will need to determine its risk level to humans or the environment for categorisation. There are three main categories for this: 1. Exempt introduction a. Chemicals which are a very low risk. b. A one-off declaration is required after you introduce the product. c. Recordkeeping is required.
AMT AUG/SEP 2020
2. Reported introduction a. Chemicals with a low risk. b. A one-off declaration is required before you introduce the product. c. Recordkeeping is required. 3. Assessed introduction a. Chemicals with a medium to high risk. b. An assessment certificate is required before you introduce the product. c. Recordkeeping is required. d. Leads to the chemical being added to the AICIS Inventory. Other information that you might need to know about your chemical includes the introduction volume and concentration, the end use and end use concentration, hazard information on the chemical, and if your chemical is in any specified class of introduction. If your chemical is a polymer, then a molecular weight is necessary. If your chemical has undergone international assessments that would also be useful to reference in your submission. All of this information can then be used to help determine the introduction category for the chemical. As part of the change, in March 2020, NICNAS published a list of chemicals with high hazards to human health and the environment for categorisation purposes under the Industrial Chemical Act. To provide introducers a tool for checking whether their chemicals are highly hazardous, NICNAS published the consolidated list of chemicals with high hazards that were based on one or more national or international information sources, such as the European Chemicals Agency (ECHA) Harmonised Classification and Labelling of Hazardous Substances (Annex VI to the CLP Regulation) and the Chemical Substances Control Law of Japan (CSCL) Class I and II Specified Chemical Substances. The list contains about 4,500 chemicals with their Australia inventory status, as well as the hazard classification data from the trusted sources.
Recommended action For more information on how to categorise your chemical introduction, please refer to the AICIS Guide to categorising your chemical importation or manufacture on the AICIS website. Laura Whiteman and Dr. Lily Hou are both senior regulatory specialists at UL, which provides innovative material and regulatory data solutions to facilitate a transparent and sustainable product supply chain. With fully automated chemical compliance software platforms, industry-leading data resources, and an unprecedented global network of regulatory expertise, UL removes barriers and solves critical challenges to help companies stay one step ahead of global regulations. For all of the latest regulatory news and the most important industry updates, you can sign up to UL’s monthly regulatory newsletter. Email: customerservice.anz@ul.com Ph: 03 9846 2751 https://msc.ul.com/en
