Australia Regulatory News

On 12 October 2022 the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 18 draft evaluation statements covering 187 industrial chemicals. Industry has until 7 Decembe...

On 12 October 2022 the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 18 draft evaluation statements covering 187 industrial chemicals. Industry has until 7 December to comment. This type of consultations has been held by the AICIS on two prior occasions, first in October 2021 (1387 substances) and then in May 2022 (157 substances).

The evaluations are a part of Australia’s evaluation roadmap for 2024 and beyond, published in September 2021 and the accompanying rolling action plan for prioritizing chemicals for evaluation. Both were implemented to accelerate the risk assessment process for industrial chemicals that can be used in the country. The aim of the evaluation roadmap is to evaluate at least 20 % of the chemicals on the Australian Inventory of Industrial Chemicals (AIIC) for which a current risk assessment is not available by 30 June 2024. This would be approximately 4200 chemicals.

Under Australia’s Industrial Chemicals Act 2019, any chemical that meets the definition of an industrial chemical (or class of industrial chemicals) may be subject to evaluation. Evaluations can cover a single chemical, a class or group of chemicals, a specific use, a specific hazard, a specific exposure, or specific circumstances of a chemical introduction.

The list of draft evaluation statements provides an overview of the evaluations including the proposed outcomes for each chemical. The substances in list cover a wide range of substances from 15 aluminium salts used in deodorants (human health risk assessment) to two aromatic hydrocarbons, pentachlorobenzene (PeCB) and hexachlorobenzene (HBC), that are known persistent organic pollutants (POPs) and that have been banned globally by the Stockholm Convention on Persistent Organic Pollutants in 2009. The draft evaluation statements for these 2 compounds suggest that they should be removed from the AIIC and thereby banned from manufacture and import in Australia.

Until the 11 October 2022 the Australian Chemicals Introduction Scheme (AICIS) is consulting on proposed alterations to the Industrial Chemicals (General) Rules 2019, regarding certain lower risk chem...

Until the 11 October 2022 the Australian Chemicals Introduction Scheme (AICIS) is consulting on proposed alterations to the Industrial Chemicals (General) Rules 2019, regarding certain lower risk chemicals when introduced in small quantities (10 kg or less in a registration year).

The AICIS has divided the proposed changes into two parts:

1. Changes to the record-keeping requirements for listed introductions at 10 kg or less in a registration year.
2. Changes to categorize introductions of chemicals at 10 kg or less in a registration year as reported.

The proposed changes intend to simplify the record-keeping obligations for manufacturers or importers who might have difficulties getting confidential or commercially sensitive information such as CAS number and name of a chemical from the overseas supplier. Instead, the AICIS would require the introducers of low-volume chemicals to “keep information that they should have or should be able to easily access”.

The proposed changes would mean that introducing volumes of 10 kg or less in a registration year of lower risk substances that meet the eligibility criteria of the AICIS could be categorised as reported.

Chemicals of higher concern, such as carcinogenic, fluorinated or persistent, bioaccumulative and toxic to the environment, would not meet the criteria for these changes.

You can submit your feedback on the proposed changes by 11.59 pm AEDT on the 11 October 2022 on https://www.industrialchemicals.gov.au/have-your-say-about-our-consultation-chemical-introductions-10-kg-or-less

According to the Australian authorities, a separate post-introduction declaration is needed for chemicals defined as “exempted” submitted during 2021- 2022. Declarations for exempted chemicals sho...

According to the Australian authorities, a separate post-introduction declaration is needed for chemicals defined as “exempted” submitted during 2021- 2022. Declarations for exempted chemicals should cover the period of 1^st September 2021-31^st August 2022 and can be submitted from 1^st August until 30^th November 2022.

A separate submission should be done for each exempted chemical, the total number of PLCs and the total number of low-concern biopolymers.

Note: post-introduction declaration presumes that an introduction for exempted chemicals has already been done. This concerns:

• polymers of low concern (PLCs)
• low-concern biopolymers
• chemicals categorised as very low risk for human health and the environment

GPC can always help you with your submission!

The registered importer or manufacturer who introduced the chemicals during the previous registration year must submit the annual declaration under AICIS. The submission starts from August 1 and ends ...

The registered importer or manufacturer who introduced the chemicals during the previous registration year must submit the annual declaration under AICIS. The submission starts from August 1 and ends on November 30, 2022. This applies to all chemical introductions, regardless of the category, the amount, or the number of chemicals. The annual declaration covers activities from 1 September 2021 to 31 August 31, 2022.

The annual declaration should include:

• the introduction categories for the chemicals you imported or manufactured during our registration year
• a declaration that all of your introductions were authorised under sections 25 to 30 of the Commonwealth's Industrial Chemicals Act 2019.

GPC can help you for the Annual Declaration.  

The new clarification from the Australian Industrial Chemicals Introduction Scheme (AICIS) explains registration obligations under various circumstances to organizations that import or manufacture ind...

The new clarification from the Australian Industrial Chemicals Introduction Scheme (AICIS) explains registration obligations under various circumstances to organizations that import or manufacture industrial chemicals or products. This includes universities, colleges, research institutes, charities, and non-profit organizations.

Being the regulatory body in Australia, AICIS on May 31 stipulated the mandatory registrations expected of relevant organizations, including organizations that import or manufacture small amount. It also does not matter if another university/organization already imports the same or similar chemicals from overseas, the process of registration will be the same, as it is for others.

The qualification process for registration applies to any organization involved in any of these activities:

• Buy chemicals from overseas for teaching or research,
• Manufacture industrial chemicals in a lab or classroom for teaching or research,
• Import or manufacture a low volume of chemicals with no threshold limit cast on the volume,
• Import or manufacture chemicals solely for non-profit research, or  
• Import or manufacture chemicals solely for a charitable purpose.  

The AICIS notice had clarified that organizations are not obliged to register blending or mixing ingredients purchased in Australia, goods and products not designed to intentionally release chemicals, or non-industrial chemicals. The AICIS has also provided information and guidance for registration regarding businesses and chemicals as well as those to-do-list after the organizations have completed the process.

On the 30th of May 2022, Australia published some evaluations under section 78 of the Industrial Chemicals Act 2019. The draft versions of these evaluations were initially published for public consult...

On the 30^th of May 2022, Australia published some evaluations under section 78 of the Industrial Chemicals Act 2019. The draft versions of these evaluations were initially published for public consultation and closed on the 28^th of March 2022.

The concerned chemicals and new evaluations are as follows:

The Australian Government published a variation of specific information requirements regarding 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl- (CAS No. 96556-05-7) on May 4, 2022. The modification and...

The Australian Government published a variation of specific information requirements regarding 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl- (CAS No. 96556-05-7) on May 4, 2022. The modification and publication are done in accordance with Section 93 of the Industrial Chemicals Act 2019.

This chemical has been assessed under the Industrial Chemicals (Notification and Assessment) Act 1989, and any registered introducer (that is, manufacturers and importers) can introduce this to Australia based on the Australia Inventory of Industrial Chemicals (AIIC) list.

The published notice states that for 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl- (CAS No. 96556-05-7), the introducers (importers and manufacturers) of this chemical shall notify the Executive Director in writing in 28 days when either of the following situations is met (excerpted from Variation of Specific Information Requirements).

• The importation volume of the chemical ≥ 10 t/y; or
• The concentration of the chemical in paints or coatings ≥ 3%.