Australia Regulatory News

During the months of September, October, and November 2023, the Australian Industrial Chemistry Introductory Scheme (AICIS) has made several updates to the Australian Inventory of Industrial Chemicals...

During the months of September, October, and November 2023, the Australian Industrial Chemistry Introductory Scheme (AICIS) has made several updates to the Australian Inventory of Industrial Chemicals (AIIC). The updates include adding new chemicals to the inventory, correcting chemical names and correction of chemical names in the inventory. Details of the updates are summarised below.

Correction of chemical names

On 23 November 2023, the AICIS announced that the names of 27 chemicals in the AIIC have been updated to the Chemical Abstracts Service (CAS) name or the CAS name has been updated. The updates do not change the identity of the chemical substances themselves. These amendments were made in accordance with section 85 of the Industrial Chemicals Act 2019. The details of the substances are listed in the table below.

Chemicals added to the Inventory

On 10 November 2023 the AICIS announced that seven substances had been added to the 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) differ from their assessment. The seven substances are listed in the table below.

Chemicals added to the Inventory following issue of assessment certificate (early listing)

On 2 November 2023, the AICIS issued a notice adding two chemical substances to the AIIC following the issuance of an early listing assessment certificates. This is in accordance with section 83 of the Industrial Chemical Act 2019. The details of the substances are listed in the table below.

Chemicals added to the Inventory (II)

On 24 October 2023 the AICIS announced that seven substances had been added to the AIIC because 5 years have passed since the assessment certificates for the chemicals were issued. The same specific information requirements as described above apply. The seven substances are listed in the table below.

Chemicals added to the Inventory following issue of assessment certificate (early listing) (II)

On 17 October 2023, the AICIS issued a notice adding seven chemical substances (fragrances) to the AIIC following the issuance of an early listing assessment certificates. The same specific information requirements as described above for early listings apply. The seven substances are listed in the table below.

Chemicals added to the Inventory (III)

On 10 October 2023 the AICIS announced that five substances had been added to the AIIC because 5 years have passed since the assessment certificates for the chemicals were issued. The same specific information requirements as described above apply. The five substances are listed in the table below.

Chemicals added to the Inventory following issue of assessment certificate (early listing) (III)

On 19 September 2023, the AICIS issued a notice adding two chemical substances to the AIIC following the issuance of an early listing assessment certificates. The same specific information requirements as described above for early listings apply. The two substances are listed in the table below.

Food Standards Australia New Zealand (FSANZ) proposes to amend its Food Standards Code to align residue limits (MRLs) for agricultural and veterinary chemicals with other national regulations.  Re...

Food Standards Australia New Zealand (FSANZ) proposes to amend its Food Standards Code to align residue limits (MRLs) for agricultural and veterinary chemicals with other national regulations. 

Regulatory Authority involved:

• Food Standards Australia New Zealand (FSANZ)

• Australian Pesticides and Veterinary Medicines Authority (APVMA)

APVMA sets maximum residue levels that are not likely to be exceeded if agricultural or veterinary chemicals are used in accordance with approved label instruction. In considering maximum residue levels (MRLs) and variations to MRLs, the APVMA considered studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice, and dietary exposure.

The following substances in particular plant and animal commodities are the subject of the proposed amendments:

Plant commodities: Fenpropidin, florylpicoxamid, abamectin, acibenzolar-S-methyl, benzovindiflupyr, chlorantraniliprole, cyanamide, cyantraniliprole, difenoconazole, dimethoate, fenpropidin, fluxapyroxad, isocycloseram, isopyrazam, omethoate, pyraclostrobin, spirotetramat, tebuconazole, tetraniliprole, trifloxystrobin, and trifludimoxazi Australian Pesticides and Veterinary Medicines Authorityroln.

Animal commodities: Fenpropidin, halauxifen-methyl, and trifluralin

Key highlights of amended version of MRL standard:

• New MRLs have been established for a variety of pesticides and veterinary compounds, including those used on new crops or to combat novel pests and diseases.

• MRLs for various pesticides and veterinary chemicals have been increased to reflect the latest scientific research on their safety.

• MRLs for various pesticides and veterinary compounds have been reduced to ensure that dietary exposure remains safe.

FSANZ has assessed the scientific data on chemicals and concluded that the proposed MRLs are safe for consumers.

Public is invited to comment on proposed amendments until 14 November 2023.

Proposed date of adoption and publication anticipated in January 2024.

On 29 September 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 20 draft evaluation statements covering 1996 industrial chemicals. The deadline for comment...

On 29 September 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 20 draft evaluation statements covering 1996 industrial chemicals. The deadline for comments is 27 November 2023.

This type of consultation has been conducted by the AICIS on four previous occasions, first in October 2021 (1387 substances), in May 2022 (157 substances), in October 2022 (187 substances) and in May 2023 (1768 substances).

Evaluation roadmap

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 prioritising chemicals for evaluation. Both have been implemented to accelerate the risk assessment process for industrial chemicals that can be used in the country. The evaluation roadmap aims to evaluate at least 20 % of the chemicals on the Australian Inventory of Industrial Chemicals (AIIC) that do not have an up-to-date risk assessment by 30 June 2024 and the remaining unassed industrial chemicals of higher concern by the end of 2030.

Under the Australian 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 may 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.

Draft Evaluation statements

The list of draft evaluation statements provides an overview of the evaluations including the proposed outcomes for each chemical. Some examples are:

• Acetoin, cinnamaldehyde, diethylene glycol, and ethylene glycol are 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).

• 2-Methoxyethyl methacrylate and 2-ethoxyethyl methacrylate where the evaluation selection analysis has indicated a potential risk to human health and the AICIS proposes to vary the terms of the Inventory for this substance. The substances are used in nail enhancement products (such as artificial nails)

The majority of the substances (approximately 1800 of the 1996 substances) are not considered for in-depth evaluation because they are no longer commercially active in Australia.

The full list of Draft Evaluation Statements can be found here.

In line with the Industrial Chemicals Act of 2019, new chemicals were introduced to the Australian Inventory of Industrial Chemicals (AIIC) after their assessment certification on October 17, 2023. Th...

In line with the Industrial Chemicals Act of 2019, new chemicals were introduced to the Australian Inventory of Industrial Chemicals (AIIC) after their assessment certification on October 17, 2023. This move reinforces Australia's commitment to keeping the industrial chemicals sector up to date and regulated.

The new chemicals on the list and their specific characteristics are as follows:

-1-Propanaminium, 2-hydroxy-N,N-dimethyl-N-[3-[(1-oxododecyl)amino]propyl]-3-sulfo-, inner salt

 CAS Number: 19223-55-3

Molecular Formula: C20H42N2O5S

- 2H-Pyran, tetrahydro-3-(phenylmethyl)

  CAS Number: 60466-73-1

  Molecular Formula: C12H16O

 Usage: Primarily for fragrance formulations in cosmetics and  household products.

- 7-Nonenal, 6,8-dimethyl-

CAS Number: 899810-84-5

Molecular Formula: C11H20O

Usage: Predominantly in fragrance formulations for end-use products.

- 9-Decen-2-one

CAS Number: 35194-30-0

Molecular Formula: C10H18O

Usage: Mainly for fragrance formulations across various products.

- Hexanal, 6-cyclopentylidene-

  CAS Number: 111998-18-6

  Molecular Formula: C11H18O

  Usage: Used in limited concentrations in cosmetics and household products.

- 2H-Pyran-2-one, tetrahydro-5-propyl-

  CAS Number: 214335-70-3

  Molecular Formula: C8H14O2

  Usage: Featured in fragrance formulations across a variety of products.

- 1,3-Dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl-

  CAS Number: 1853175-99-1

  Molecular Formula: C15H26O2

  Usage: Utilized majorly in fragrance formulations for multiple end-use products.

Manufacturers and importers should be aware that if the circumstances of the import or manufacture differ from the initial assessment, the authorities must be notified within 28 days.

On 9 October 2023, the Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) opened consultations on the proposed scheduling decisions for short chain chlorinated paraffi...

On 9 October 2023, the Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) opened consultations on the proposed scheduling decisions for short chain chlorinated paraffins under the Industrial Chemicals Environmental Management Standard (IChEMS).  

The substances in question are all classified as Persistent Organic Pollutants (POPs) under the Stockholm Convention. These substances have the potential to inflict significant or irreversible damage to the environment unless they are appropriately controlled. The consultations are open for feedback until 8 November 2023 and submissions can be made here. Providing feedback on the proposed decisions will help the Australian governments and businesses manage the environmental risks associated with these chemicals. 

Short chain chlorinated paraffins 

Short-chain chlorinated paraffins (SCCPs) refer to a category of chlorinated paraffin chemicals composed of straight-chain alkanes. It is important to note that SCCPs have never been manufactured in Australia, but have been used in a variety of  industries. They have been used as a dual-purpose flame retardant and plasticizer in polyvinyl chloride (PVC) products, as lubricants in metalworking, and in the leather treatment process. 

The DCCEEW is seeking feedback on short-chain chlorinated paraffins (SCCPs). The scheduling decision is for Schedule 7 of the IChEMS Register. If adopted, the import, manufacture, use and export in Australia will be prohibited from 1 July 2024.  

The Industrial Chemicals Environmental Management Standard 

IChEMS is a national approach in Australia that aims to efficiently manage the use, storage, handling and disposal of chemicals. By establishing standardised environmental protocols for the handling of industrial chemicals, IChEMS streamlines the process for industry to choose less hazardous alternatives. Under IChEMS, chemicals will be listed on the IChEMS Register in one of seven schedules based on their risk characteristics to provide information on their relative environmental risk. The IChEMS Register will also include risk-based controls that should be applied to protect the environment. Industrial chemical uses that pose a greater risk to human health and the environment will be subject to more stringent controls. 

IChEMS Register Schedules 

In the IChEMS Register, Schedules 6 and 7 list the industrial chemicals of greatest environmental concern, e.g. chemicals that are persistent, bioaccumulative and toxic, such as POPs. All uses of chemicals in Schedules 6 and 7 are being phased out, except for essential uses. Schedules 2 to 5 list industrial chemicals of medium environmental concern. They are subject to controls that are proportionate to the nature and level of risk. Schedule 1 lists the industrial chemicals of lowest concern. 

Previous consultations 

In July 2023 the DCCEEW held consultations on the proposed scheduling decisions for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonate (PFHxS), and pentachlorobenzene (PeCB). Those consultations closed on 1 September 2023. Furthermore, in September 2023, the DCCEEW  also held consultations on the proposed scheduling decisions for brominated flame retardants (BFRs) and these consultations are still open till 25 October 2023.  

It is time for registered importers or manufacturers who introduced industrial chemicals into Australia during the previous registration year to submit their annual declaration to the Australian Indus...

It is time for registered importers or manufacturers who introduced industrial chemicals into Australia during the previous registration year to submit their annual declaration to the Australian Industrial Chemicals Introduction Scheme (AICIS). The deadline for submission is 30 November 2023. This applies to all chemical introductions, regardless of category, quantity, or number of chemicals. The annual declaration covers activities from 1 September 2022 to 31 August 2023.  

The annual declaration should include: 

• The introduction categories for the chemicals imported or manufactured during the registration year. 

• A declaration that all introductions were authorised in accordance with sections 25 to 30 of the Industrial Chemicals Act 2019. 

• It should also be noted that an agent or consultant cannot submit the annual declaration on behalf of a company.  

• A separate post-introduction declaration (PID) must be submitted for each chemical categorised as very low risk for human health and the environment that is introduced in a registration year. 

• A separate post-introduction declaration must be submitted for the total number of polymers of low concern (PLCs) introduced during the registration year and a separate declaration must be submitted for the number of low-concern biopolymers introduced during the registration year. 

For more information you can contact us via the following email: compliance@gpcregulatory.com 

The Australian Government has issued an open invitation to the community to provide valuable input on a comprehensive set of proposed changes to the categorization of chemical introductions. These cha...

The Australian Government has issued an open invitation to the community to provide valuable input on a comprehensive set of proposed changes to the categorization of chemical introductions. These changes include the strengthening of reporting and record-keeping obligations under the Australian Industrial Chemicals Introduction Scheme (AICIS). Furthermore, the AICIS has carefully identified specific facets within the General Rules that require strengthening to ensure the safeguarding of human health and the environment, as well as to clarify of certain requirements. 

Within this consultation, the AICIS is highlighting several key proposals, including: 

1. Transitioning from written undertakings to a streamlined system of record-keeping and thereby simplifying compliance procedures. 

2. Enhancing the recognition and use of the International Nomenclature of Cosmetic Ingredients (INCI) names for both reporting and record-keeping purposes. 

3. Revise the categorization criteria to provide tangible advantages to various stakeholders, including soap manufacturers, chemical introducers involved in flavoring and fragrance blends, and those working with controlled hazardous chemicals. 

4. Extending the criteria and/or reporting requirements to strengthen measures to protect of both health and the environment. This includes measures aimed at preventing the inadvertent categorization of persistent organic pollutants (POPs) as exempted or unreported introductions. 

Manufacturers and importers have until November 9, 2023 to submit their views and comments on these proposals.