Using our extensive regulatory and scientific expertise, Intertek can help successfully guide your novel substances to Australia through the new AICIS process.
In May of 2015, the Australian Government announced its intention to implement reforms to the way in which industrial chemicals are regulated. The reforms streamline the process of assessing industrial chemicals to reduce the regulatory burden and to make regulatory effort more proportionate to risk.
The legislation is contained primarily in the Industrial Chemicals Act 2019 (the Primary Act), the Industrial Chemicals (General) Rules and the Industrial Chemicals Categorisation Guidelines. The Industrial Chemicals Act which was passed by Parliament in February of 2019 and received Royal Assent in March of 2019, creating a new framework for the regulation of imported and manufactured industrial chemicals. The new scheme referred to as the Australian Industrial Chemicals Introduction Scheme or AICIS replaced the National Industrial Chemicals Notification and Assessment Scheme, referred to as NICNAS on July 1, 2020.
The requirements to introduce a new industrial chemical require that companies register their business before introduction (import/manufacture) and that they meet the requirements of a category of introduction based on the level of risk to human health and the environment.
Intertek helps chemical product importers, manufacturers and end users navigate the complexities of the AICIS. Our chemicals team has extensive expertise, experience and industrial knowledge allowing us to understand our client’s business needs, anticipate any compliance challenges and to develop a strategic path forward enabling companies to save time and money.
Intertek offers the following chemical notification-related services to the producers, suppliers and users of industrial chemicals:
- Surveillance and interpretation of regulatory scheme;
- Conduct chemical analysis to determine the need for, and nature of, pre-manufacture/pre-import/pre-market notifications including assistance with requesting the search of the confidential inventory;
- Categorize chemical introductions (i.e. listed, exempted, reported, assessed, commercial evaluation) by evaluating and understanding the hazards associated with your substance to assist in categorization determinations;
- Development of notification strategies;
- Design, implementation, and stewardship of testing programs;
- Develop and defend waiver requests and surrogate data via "read-across" approaches, modelled data and method variations;
- Prepare notification dossiers that ensure prompt acceptance and assessment by the authorities;
- Post-notification maintenance including supporting annual declarations, inventory listing requests, applicable record-keeping and reporting requirements dependent on the introduction category; and
- Support legal advisors by providing experienced insight into resolving issues of notification non-compliance.
Intertek's experts will conduct a thorough evaluation of your substance, assist with notification strategies or exemptions, and ensure your notification is professionally submitted according to the requirements of the Australian Industrial Chemicals Introduction Scheme (AICIS). Intertek can identify strategies to avoid the commission of new studies where possible through the use of analogue substance data, waivers and computational modeling such as Quantitative Structural Activity Relationships (QSAR).