Australia Regulatory News

On 23 March 2023 the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 17 draft evaluation statements covering 1768 industrial chemicals. The deadline for comments is ...

On 23 March 2023 the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 17 draft evaluation statements covering 1768 industrial chemicals. The deadline for comments is 19 May 2023. This type of consultations has been held by the AICIS on three prior occasions, first in October 2021 (1387 substances), in May 2022 (157 substances) and in October 2022 (187 substances).

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 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.

The list of draft evaluation statements provides an overview of the evaluations including the proposed outcomes for each chemical. For example, benzaldehyde is evaluated in order to provide information on human health risks, focusing on the risk to public health from the use of the chemical in e-cigarettes (vaping products). Another example is 1-chloro-4-(trifluoromethyl)-benzene where evaluation selection analysis has indicated a potential human health risk and the AICIS proposes to vary terms of the Inventory for this substance. Most of the substances (approximately 1500 of the 1768) are not considered for in depth evaluation since they are no longer commercially active in Australia.

On 10 January 2023 a number of changes to the Australian Inventory of Industrial Chemicals (AIIC) were announced by the AICIS. After an evaluation under Part 4 of the Industrial Chemicals Act 2019...

On 10 January 2023 a number of changes to the Australian Inventory of Industrial Chemicals (AIIC) were announced by the AICIS.

After an evaluation under Part 4 of the Industrial Chemicals Act 2019, the AICIS has decided to remove the inventory listings of two Persistent Organic Pollutants (POPs) from the AIIC. The conclusion of the evaluation was that the risks to the environment from the introduction or use of the two substances cannot be managed with the existing regulatory framework. The following two substances will therefore be removed from the AIIC on 8 February 2023.

The above-mentioned evaluation also resulted in variations to inventory listings for two substances. The variation means that an obligation to provide specific information to the AICIS will be added to the terms of listing for the to following compounds from 8 February 2023.

Furthermore, the following industrial chemicals were added to the AIIC because 5 years have passed since the assessment certificates for these compounds were issued. Obligations to provide information about the new substances apply. The AICIS must be informed within 28 days if the circumstances of the importation or manufacture (introduction) are different to their assessment.

On 15 November 2022 the Australian Industrial Chemicals Rules 2019 has been amended regarding introductions of 10 kg or less. The amended rules, Industrial Chemicals (General) Amendment (Introductions...

On 15 November 2022 the Australian Industrial Chemicals Rules 2019 has been amended regarding introductions of 10 kg or less. The amended rules, Industrial Chemicals (General) Amendment (Introductions of 10 kg or Less) Rules 2022, is a result of a consultation held by the Australian Chemicals Introduction Scheme (AICIS) in October 2022.

For listed introductions (import or manufacture) it is now possible to choose to keep a simple set of records, if the introduced chemical is listed in the Australian Inventory for Industrial Chemicals (AIIC) and the combined volume of the chemical that is introduced in an AICIS registration year (from 1 September to 31 August) is 10 kg or less. This means that if the introducer of the chemical knows the CAS number to the chemical, they must keep a record of the CAS number and the CAS name (or INCI) name. If the introducer does not know the CAS number, they must keep a record of the CAS name, IUPAC name, or INCI name as well as records to indicate that the chemical is listed on the inventory. This information could be obtained for the chemical supplier.  

Reported introductions of 10 kg or less now have reduced reporting and record-keeping obligations compared to other reported introduction types. A pre-introduction report (PIR) must be submitted if the chemical to be introduced is in the reported category and is not on the AIIC or if it is on the AIIC, but the introduction is outside the parameters of the defined scope of assessment. Introducers must keep records for 5 years including written or electronic record of the chemical names provided in the PIR, the names of any products containing the chemical that has been imported into Australia, and records showing that the criteria for reported introduction 10 kg or less are met.

Other changes made as a result of the feedback the AICIS received during the consultation:

• The definition of GHS has been changed so that it now refers to the GHS edition in use by SafeWork Australia. This signifies that the Industrial Rules 2019 will not need to be amended when SafeWork Australia updates its GHS edition.
• Introductions can be classified as reported as long as the introducer does not hold information to suggest that the chemical does not satisfy the criteria for germ cell mutagenicity, carcinogenicity, or reproductive toxicity hazards classes in the GHS.

On 16 November 2022 the Australian Industrial Chemicals Introductory Scheme (AICIS) announced that 8 substances have been added to the Australian Inventory of Industrial Chemicals (AIIC) because 5 yea...

On 16 November 2022 the Australian Industrial Chemicals Introductory Scheme (AICIS) announced that 8 substances have been added to the Australian Inventory of Industrial Chemicals (AIIC) because 5 years have passed since the assessment certificates for the chemicals were issued. This is in accordance with Section 82 of the Industrial Chemicals Act 2019. Obligations to provide information about the new substances apply. The AICIS must be informed within 28 days if the circumstances of the introduction (importation or manufacture) are different to their assessment.

The substances added to the AIIC are:

On the same day the AICIS announced that the inventory listing for the following substance was changed since the approval to treat the proper name of the substance as confidential business information (CBI) had been revoked:

1,3-Benzenedicarboxylic acid, polymer with (2E)-2-butenedioic acid, 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and hexanedioic acid, (octahydro-4,7-methano-1H-indenyl)methyl ester (CAS number: 2093197-30-7)

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!