Australia Regulatory News

On November 3rd 2020, Australian government announced that introducers (manufacturers or importers) of cosmetic toothpaste or oral hygiene products need to register their business only if their pr...

On November 3rd 2020, Australian government announced that introducers (manufacturers or importers) of cosmetic toothpaste or oral hygiene products need to register their business only if their products meet the requirement of Therapeutic Goods (Excluded Goods) Determination 2018.  The ingredients used in cosmetic toothpaste or oral hygiene should categorized in any of the 5 main categories under AICIS.

Cosmetic toothpaste or oral hygiene products are those which meet the following criteria:

• Do not contain any substance included in Schedules 2 (Pharmacy Medicine), 3, 4 or 8 to the Poisons Standard, these schedules contains list chemicals and controlled drugs which safe use may require advice from pharmacists or professionals.
• Advertised or presented for supply so that the only benefits claimed to result from the use of the product are consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay
• Do not claim as therapeutic products

The registrants should keep records for 5 years of chemical introductions even after stopping introductions in Australia territory, to confirm that they comply with laws.

Registrants must submit annual declarations regardless the introduction category by 30 November after end of every registration year.

If toothpaste and oral hygiene products are medicines or marketed as having therapeutic effects, then they are classed as ‘therapeutic’ goods and regulated under Therapeutic Goods Administration (TGA) doesn’t have any implications under AICIS. 

Chemicals with CAS number 169118-66-5 and 144093-88-9 have been added to Australian Inventory of Industrial Chemicals in accordance with section 82 of the Industrial Chemicals Act 2019 after completion of 5 years since the assessment certificates were issued.

Information on Schedule 2,3,4 and 8:

Schedule 2: Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.

Schedule 3:Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

Schedule 4: Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.

Schedule 8: Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

Australia issued new legislation for toys containing magnets,” Consumer Goods (Toys Containing Magnets) Safety Standard 2020.” This new legislation will repeal the existing “Consumer...

Australia issued new legislation for toys containing magnets,” Consumer Goods (Toys Containing Magnets) Safety Standard 2020.” This new legislation will repeal the existing “Consumer Product Safety Standard for Children’s Toys Containing Magnets (Consumer Protection Notice No. 5 of 2010) (Federal Register of Legislation No. F2010L00195).  Any children’s toys containing magnets must comply with this new requirement from August 28, 2021.

This law will be applicable to all magnetic toys designed for use in play by a child under 14 years of age, supplied with one or more magnets or magnetic components.

The new law mandates to comply with the following clauses from any one of the instruments mentioned in the below table.

During the transition period till 27 august 2021, magnetic toy must comply with either any one of the following section requirements, Australian/New Zealand Standard (section 9), European Standard (section 10), International Standard (section 11), US Standard (section 12) or the Consumer Product Safety Standard for Children’s Toys Containing Magnets (Consumer Protection Notice No. 5 of 2010).

However, this new law is not applicable to sporting goods, camping goods, bicycles, home and public playground equipment, trampolines, electronic game units, models powered by combustion or steam engines, and fashion jewelry.

Australia announced in the beginning of year 2020 about their decision to adapt 7th Revision of the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) from 1st J...

Australia announced in the beginning of year 2020 about their decision to adapt 7th Revision of the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) from 1st July 2020. This will be adopted under the Model Work Health and Safety (WHS) laws for workplace hazardous chemicals. 

Australia will adopt GHS Revision 7 with a 2 year transition period which will allow manufacturers and importers time to prepare new classifications, labels and safety data sheets for hazardous chemicals to meet GHS Revision 7 requirements. 

Suppliers and users of hazardous chemicals will not be affected by the move to GHS Revision 7 and will be able to continue to supply and use chemicals classified and labelled under GHS Revision 3 until their stocks run out. 

Safe Work Australia held face to face consultation sessions as well as online public consultations in June and July 2019. With these consultations all respondents supported moving from GHS Revision 3 to Revision 7. Australia states that this change will ensure Australia’s requirements for the classification and labelling of workplace hazardous chemicals remain best practice and are aligned with their key international trading partners in chemicals. 

Suggested steps: 

• For manufacturers and importers: Once the Revision 7 guidelines for Australia are released, identify the changes required for SDS and labels. Ensure that these changes are completed by 30th June 2022. 

• For suppliers and users: Be aware that product labels and SDS may have some small changes with the transition to GHS Revision 7. 

• Subscribe to GPC newsletter to remain updated on this topic and further developments. 

In Australia, new scheme the Australian Industrial Chemicals Introduction Scheme (AICIS) replaced 30 year old National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on&nbs...

In Australia, new scheme the Australian Industrial Chemicals Introduction Scheme (AICIS) replaced 30 year old National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1st July 2020. This new scheme regulates the introduction i.e. manufacture and import of industrial chemicals in Australia. It is advisable for companies to understand the new requirements and different categories for new introductions to comply with the new Scheme.  

The aim of new scheme is to protect the health of Australian population and environment, while also keeping industry competitive and promoting access to safer chemicals. 

Key Changes from 1st July 2020: 

• There will be 6 categories of introduction with different regulatory requirements that are proportionate to the likely level of risk 

• Lower risk chemical introductions will have streamlined introduction pathways, resulting in reduced regulatory burden for industry. 

• There will be improved protections for the public, workers, and the environment towards higher risk chemicals. 

• Improved approaches to reviewing chemicals on the market. 

• There will be increased focus on pre and post-introduction evaluation and monitoring of chemicals.  

• Restriction on the use of animal test data for supporting the introduction of ingredients used in cosmetics. 

Section 21 of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) allows for the introduction of new chemicals into Australia provided the chemicals meet certain requirements sti...

Section 21 of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) allows for the introduction of new chemicals into Australia provided the chemicals meet certain requirements stipulated in subsections 21(4) and 21(6) of the Act. New chemicals which satisfy the requirements of subsections 21(4) and 21(6) are exempt from the notification requirements of the legislation. A summary of the exemption categories and their criteria for use is provided in Table 1.

Table 1 exemption categories

Industrial chemical introducers are required to report to NICNAS every year on any chemical introduced under these exemption provisions (section 21AA). Reported information on these chemicals provided during 2019-20 has been collated and the following is a detailed summary of this information.

Number of chemicals introduced

A total of 15,379 new chemicals were reported during 2019-20 as being introduced under the exemption provisions during the previous registration year. This includes 5,054 chemicals reported as being introduced at up to 10 kg for which no chemical name or other details were provided. The distribution of fully reported chemicals among the six exemption categories is shown in Figure 1.

Use of chemicals introduced

Figure 1. Fully reported exempt chemical by category

Cosmetic chemicals represent 84% of all chemicals reported under the exemption provisions with 90% of these cosmetic chemicals being introduced under the <100kg cosmetic exemption category.

Of the chemicals for which full details were reported (identity and use category), Education, Research & Development, Printing, and Surface Coatings represent the most common non-cosmetic chemical use categories. These use categories account for 43% of all chemicals reported for non-cosmetic uses. The distribution of chemicals introduced under the non-cosmetic exemption provisions across various use categories is illustrated in Figure 2.

Figure 2. Industry distribution of non-cosmetic exempt chemicals

To reduce the burden on reporting introducers, the exact quantity of an introduced exempt chemical is not required. Introducers are however required to report a quantity range for each chemical (0-10 kg, >10-100 kg, >100 kg). The distribution of fully reported chemicals across these quantity ranges are provided in Table 2.

Eighty-nine percent of all reported chemicals were introduced at quantities of 10 kg or less. 28 chemicals were reported as exceeding the 100 kg threshold in either the ≤100 kg cosmetic or non-cosmetic exemption category. Instances of non-compliance associated with these chemicals have been managed as self-reported non-compliance.

Chemicals not previously reported

Nine percent of reported chemicals were reported for the first time in 2019-20 based on chemicals for which a CAS number was provided.

Reporting organisations

A total of 279 organisations provided information on exempt category chemicals. A summary of the number of chemicals reported by these organisations is provided in Table 3.

Table 3. Number of chemicals reported per organisation

Fifty-four percent of reporting organisations reported ten or fewer chemicals being introduced under the exemption provisions. Ten percent of reporting organisations reported greater than 100 chemicals.

Some changes to the Guidelines you need to know about before 1 July. The Categorisation Guidelines set out technical details and requirements to support introducers to categorise introductions of i...

Some changes to the Guidelines you need to know about before 1 July.

The Categorisation Guidelines set out technical details and requirements to support introducers to categorise introductions of industrial chemicals. The Executive Director of AICIS issues the Categorisation Guidelines.

These Guidelines will be formally issued by the Executive Director on the AICIS website on 1 July 2020.

It was earlier, in last December informed by Executive Director, about the key changes made to the Categorisation Guidelines following extensive stakeholder consultation. The Categorisation Guidelines with these changes are available on this site.

Changes to the Categorisation Guidelines

the following minor/editorial changes:

• corrected some typographical errors
• reordered some of the text
• made the information requirements clearer for:
  • UV filters
  • chemicals with an end use in tattoo inks
  • highly branched organic chemicals
  • chemicals with an end use as a biocidal active

Other changes

Persistent and bioaccumulative hazard characteristic – waiver for high molecular weight polymers

The waiver for the persistent and bioaccumulative hazard characteristic for high molecular weight polymers (in part 6.28.2) consistent with the waiver for the persistent, bioaccumulative and toxic hazard characteristic. This waiver applies to high molecular weight polymers with:

• < 25% low molecular weight oligomeric species <1,000g/mol AND
• <10% low molecular weight oligomeric species <500g/mol

Options for in silico information

Changes for the Derek Nexus in silico model so that it can now be used for more human health hazard characteristics (see Part 8.2).

NOEC (no observed effect concentration)

Removed mention of NOEC from places that talk about acute aquatic toxicity, as NOEC is only relevant for chronic aquatic toxicity.

The Categorisation Guidelines with these changes will be available from 1 July on our new website.

NICNAS  (National Industrial Chemicals Notification and Assessment Scheme) officially retires on 30 June 2020 and will be succeeded by the Australian Industrial Chemicals Introduction Scheme (AIC...

NICNAS  (National Industrial Chemicals Notification and Assessment Scheme) officially retires on 30 June 2020 and will be succeeded by the Australian Industrial Chemicals Introduction Scheme (AICIS) on 1 July 2020.

On 1 July, NICNAS Business Services will be replaced by AICIS Business Services with a new web address — https://business.industrialchemicals.gov.au.

AICIS Business Services portal will include many new features and applications to help businesses to complete their transactions online, including:

• Submitting a pre-introduction report

• Applying for an assessment certificate

• Applying for protection of your confidential business information or flagging information as confidential

There are other types of applications that require you to download PDF forms, but you’ll submit these online – no more emailing, posting or faxing required.

Your NICNAS account will automatically transfer to AICIS Business Services

You can use the same login details that you’ve been using for NICNAS Business Services. To access AICIS Business Services from 1 July, use the web address above or click on the ‘Login’ button on our brand new AICIS website, which also launches on 1 July.