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REGULATORY AFFAIRS: The new Australian Industrial Chemical Introduction Scheme

REGULATORY AFFAIRS: The new Australian Industrial Chemical Introduction Scheme

Chemicals in Australia are regulated under a number of schemes. If a chemical is not for a therapeutic, agricultural, veterinary or food use, it is considered an industrial chemical. They are regulated to aid in the protection of the Australian people and the environment from potential risks associated with the introduction and use of the chemical and includes a broad range of chemicals used in inks, plastics, adhesives, paints, glues, solvents, cosmetics, soaps and many other products.

The Industrial Chemicals Act 2019 (IC Act 2019) received Royal Assent on 12 March 2019. The IC Act 2019 establishes a new regulatory scheme, the Australian Industrial Chemicals Introduction Scheme (AICIS), for the importation and manufacture of industrial chemicals in Australia. AICIS will replace the current National Industrial Chemicals Notification and Assessment Scheme (NICNAS) from 1 July 2020.

AICIS will make regulatory effort more proportionate to risk, promote safer innovation by encouraging the introduction of lower risk chemicals and will continue to protect the Australian people and the environment from any harmful effects of industrial chemicals. The main changes resulting from this regulatory reform are:

– The regulatory effort will be based on the likely risk of a chemical introduction by defining 6 categories of introduction with different regulatory requirements proportional to the likely level of risk; the concentration of the pre-introductory assessment on higher risk chemical introductions; focusing more on post-introductory assessment and monitoring to help maintain the protection of the health and safety of the public, workers and the environment;

– Less risky chemical introductions will have simplified introduction routes, resulting in reduced regulatory burden for industry, encouraging the introduction of new, more exological and safe industrial chemicals, including the replacement of existing, more dangerous chemicals; reducing costs for companies and consumers who use less risky chemicals; reduction in the time needed to introduce chemicals classified as exempt / reported in the market compared to the current regulatory scheme, in addition to no notification fees;

– Intense protection will be promoted for the public, workers and the environment against chemicals classified as most at risk, which will provide the ability to impose conditions for introducing high-risk chemicals and there will also be the possibility of refusing permission to introduce the product. chemical or interruption of its introduction, if it is identified that its risks to human health and the environment cannot be managed (which does not exist in the current scheme);

– Greater use of international assessment materials, including through a simplified introduction path for presentations that have been assessed by a trusted regulatory organization.

While the new scheme will begin on 1 July 2020, early regulatory changes are now in effect under the current scheme. These changes will reduce regulatory burden for introducers of some lower risk chemicals such as polymers of low concern.

More details on the early regulatory changes can be found on the NICNAS website.

Mariana Scarfoni Peixoto
Líder de Assuntos Regulatórios

REGULATORY AFFAIRS: The new Australian Industrial Chemical Introduction Scheme