Transition from NICNAS to AICIS finishes today (31st August 2022).

In many cases Introducers have not managed to meet the AICIS categorisation and record keeping requirements during the two year transition from NICNAS to AICIS.

AICIS has announced some new provisions to assist with the transition from the 1st of September 2022. These provisions are as follows;

1. Listed introductions – transition period extended

AICIS requires that certain records be kept for ‘Listed Introductions’. These records must include the identity of the chemical or a ‘Written Undertaking’ from the chemical supplier. AICIS have extended the timeframe to meet these requirements until the 30th of November 2023.

Until this date, AICIS will accept either the written confirmation that the introducer would have had under NICNAS confirming that the chemical is listed on the Australian Inventory of Chemical Substances (NICNAS inventory) or copies of correspondence to show that a ‘Written Undertaking’ has been requested to meet the AICIS requirements.

2. Low volume introductions of chemicals – changes to the Rules will be proposed 

AICIS will conduct a consultation shortly regarding proposed changes to the Industrial Chemicals (General) Rules 2019 (the Rules) for introductions of chemicals at less than or equal to 10 kg in a registration year. 

It is expected that these changes will not be a simple de minimis exclusion for 10 kg.

3. Other changes – chemicals previously introduced under the NICNAS exemptions 

There will be no extension for the transition of certain NICNAS exemptions to AICIS.

AICIS have announced that they will conduct the following activities;

  • explore options to the relevant issues raised by stakeholders that are related to the categorisation, reporting and record keeping requirements of these introductions under AICIS. 
  • consult with stakeholders (including industry and community) on the issues and possible solutions. 

If you are experiencing any issues with the transition from NICNAS to AICIS or have encountered issues with compliance post transition, please contact Seren for advice and assistance.

Is your cosmetic considered a therapeutic good in Australia?

Products that are considered cosmetics in other jurisdictions may be considered therapeutics in Australia based on the following factors

  • the intended use of the product
  • the ingredients
  • the claims made regarding the indication or effectiveness of the product
  • the overall presentation of the product and context
  • the existing regulatory controls

Therefore, advertising material may result in the product being considered a therapeutic good in Australia. 

The TGA has released a learning resource regarding the effect of advertising material and product claims on the regulatory pathway.

Advertising: when cosmetics are regulated as therapeutic goods | Therapeutic Goods Administration (TGA)

Please contact Seren for advice and assistance with cosmetic regulatory matters.

AICIS Post Introduction Declarations are now due.

If your introduction is one of the following;

polymers of low concern

low-concern biopolymers

chemicals that you have categorised as very low risk for human health and the environment

Then a one-off Post Introduction Declaration (PID) is required following the first introduction of the chemical to Australia.  Declarations may be submitted via the AICIS Business Services Portal.

This PID is due by the 30th of November 2021 and it covers the period of the 1st of July 2020 to the 31st of August 2021. 

The PID is separate to the Annual Declaration and is only required once. 

Please contact Seren for advice and assistance with Post Introduction Declarations. 

Reminder – AICIS Annual Declarations are now due.

All Australian importers and manufacturers of chemicals are required to submit an annual declaration via the AICIS Business Services Portal.  The declaration form is now available. 

The registration year runs from the 1st of September to the 31st of August.  With the declaration deadline of the 30th of November. 

Please contact Seren for advice with annual declarations. 

New Zealand implementation of GHS 7 takes effect on the 30th of April 2021 – implications for existing substances with Individual Approvals or under a 2017 Group Standard.

New Zealand’s updated hazard classification system comes into effect in three weeks’ time.   This new system is in line with GHS 7 and replaces the 2001 HSNO classification system. 

There is a 4-year transition period for those substances with current Individual Approvals and for those under an existing Group Standard. 

Recently the NZ EPA revoked more than 5000 Individual Approvals.  These substances are now covered by Group Standards. Reassigned substances will require updated self-assignment records.

If you believe your substances is covered by an Individual Approval, please contact Seren to confirm and for advice. 

Some Group Standards have updated scopes, i.e., aerosol group standards.  Therefore, it is recommended that substances assigned to existing Group Standards are reviewed and, if required, assigned to a more appropriate updated Group Standard. 

Please contact Seren for advice or review of existing approvals either Individual or Group Standard Approvals.

Alcohol Based Hand Sanitisers – New ACCC Standard for labelling

The new Consumer Goods (Cosmetics) Information Standard 2020 was created this week and took effect on the 25th of November 2020.

Section 11 of this standard outlines specific labelling requirements for alcohol based hand sanitisers that meet the definition of a ‘cosmetic’.

‘Alcohol’ has been defined in the standard as;

includes, but is not limited to, ethyl alcohol (ethanol), isopropyl alcohol and alcohol denat.

The standard has a 180-day transitional period ending on the 23rd of May 2021.

Please contact Seren for advice or review of labels for cosmetics including hand sanitising products.

GHS 7 – Safework Australia update the model Work Health and Safety Regulations (Hazardous Chemicals) Amendment 2020

Australia will begin the two-year transition to GHS 7 from January 1 2021. 

The model Work Health and Safety Regulations (Hazardous Chemicals) Amendment 2020 and the explanatory statement published in August 2020 have been updated.  These updates include rectifying the requirement to re-label historical stock in certain circumstances. 

Please contact Seren for advice or assistance regarding the transition to GHS 7

Australian TGA Post-market review of face masks

Face masks which meet the definition of a medical device must be included on the Australian Register of Therapeutic Goods (ARTG) prior to supply.  Such masks are those that are intended to protect the wearer from the spread of disease, illness, and infection. 

The global pandemic resulted in a greater demand for such face masks and thus an increase in class I medical device listings on the ARTG.  Additionally, face masks were included under an emergency exemption to support the National Medical Stockpile, resulting in an increase in importation and manufacture of face masks. 

The Australian Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks that are included on the ARTG, including those introduced to support the stockpile.  This review is resulting in the cancellation of ARTG listings.

Suppliers of face masks are responsible for ensuring all regulatory requirements are met.  Including conformity of the product. 

Please contact Seren for further information on the evidence that must be available when sponsoring a listed medical device or if you have any concerns regarding an ARTG listing.  

APVMA – Pack size variations

The APVMA have advised that the variation of pack sizes constitutes a ‘change to the relevant particulars’ of a registered product.  Such changes require a Notifiable Variation (NV) application. 

This can be avoided by registering pack sizes as a range rather than discrete packs during the original registration.

If you would like assistance with pack size variations or would like to alter the registered pack sizes to a range, please contact Seren for advice.

Medical Device Post-market Reviews

The Australian Therapeutic Goods Administration (TGA) has developed a new Post Market Review Compliance Dashboard as a process of responding to a post-market review and sending associated documentation.

Launching on the 19th of October 2020, this new dashboard may be accessed via the TBS and provides a single point to access the reviews (open and closed) and upload required information.

Please contact Seren for further information on how we can assist with medical device post market review.

APVMA Advice on Product and Label Variations.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has provided advice regarding the types of product or label updates that can be made without requiring APVMA application or notification.

Such variations should not impact on the registration particulars or condition and may include the following;

  • corrections to typographical errors and spelling mistakes
  • updating a Mode of Action group
  • updating reference to a product holder on a label if this has changed
  • compatibility statements (this excludes ‘incompatibility’ statements that have been required by the APVMA)
  • changes to packaging material
  • changing from one source of approved active constituent to another.

Please contact Seren for further information on how we can assist with APMVA label variations.

AICIS launches new website

Australian Industrial Chemicals Introduction Scheme (AICIS) commenced on the 1st of July 2020. 

Therefore, AICIS has now launched a new website

https://www.industrialchemicals.gov.au/

This website allows searching of the Australian Inventory of Industrial Chemicals (the Inventory).

Please contact Seren for further information on how we can assist with AICIS compliance and inventory searching.

AICIS record keeping obligations

AICIS has compliance – monitoring activity and enforcement powers that are different to those that existed under NICNAS. 

AICIS has identified that some introducers are not able to readily produce evidence that they are meeting the record keeping obligations.  In particular, evidence of importation volumes. 

AICIS are encouraging Introducers to have written agreements in place with agents and manufacturers to prove they’re lawfully importing or manufacturing industrial chemicals.   

Please contact Seren for further information on how we can assist with record keeping and agreements.

NICNAS Reforms – Are you AICIS ready? 

The new regulatory scheme will commence on the 1st of July 2020. 

The AICIS Categorisation process is unique and there is rarely a straightforward comparison between a NICNAS permit or exemption and an AICIS category. 

Transition periods are in place for chemicals introduced under current exemptions and permits. 

Please contact Seren for further information on the transitional arrangements and how we can assist with categorisation under AICIS.

Hard Surface Disinfectants and Hand Sanitisers and COVID – 19.

The regulation of hard surface disinfectants in Australia has increased interest due to the COVID-19 situation. 

The TGA has updated the instructions for disinfectant testing to include the relevant surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19.  

Additionally, the TGA are expediating disinfectant applications which have claims relating to COVID-19. 

Hand sanitisers with specific claims (including viricidal claims) are considered therapeutic goods that require inclusion on the Australian Register for Therapeutic Goods (ARTG) unless subject to specific exemptions. 

In response to the COVID-19 situation the TGA released the Therapeutic Goods (Excluded Goods – Hand Sanitisers) determination 2020.  This determination details specific formulation and requirements which will exclude specific hand sanitiser formulations from the Therapeutic Goods Legislation.  Such products may make specific claims yet will be regulated as consumer goods. 

Please contact Seren for further details and assistance with meeting the regulatory requirements for hard surface disinfectants and hand sanitisers. 

NICNAS Reforms – Early Regulatory Changes are now in effect.

The new regulatory scheme will commence on the 1st of July 2020. However early regulatory changes are now in effect. These changes are intended to reduce the regulatory burden for certain ‘low risk’ chemicals. These changes include the following;

  1. Removal of annual reporting obligations for permits and self-assessed certificates.
  2. Reduced timeframes for Approved Foreign scheme assessments
  3. An exemption for Polymers of Low Concern (PLC)
  4. Amendment of the PLC criteria
  5. Amendment of the definition of a synthetic polymer
  6. Removal of SDS and label requirements for low volume cosmetic products

Please contact Seren for further information and conditions of the above early changes.


Standard for Disinfectants and Sanitary Products – Therapeutic Goods Order 104.

Therapeutic Goods Order (TGO) 54 ‘Standard for Disinfectants and sterilants’ has been replaced with TGO 104: standard for Disinfectants and Sanitary Products.

Additionally the TGA has separated out the schedules of the obsolete TGO 54, and made them available as the TGA instructions for disinfectant testing.

Additional changes and further guidance’s are expected throughout 2019. If you would like further information please contact Seren.


Country of origin labelling for complementary healthcare products

The Australian Competition and Consumer Commission (ACCC) has released a guidance for the complimentary healthcare industry to inform how the safe harbor defences under the Australian Consumer Law applies to their products.

This new guidance clearly describes the obligations under section 255 of the Australian Consumer Law.

If you would like further information please contact Seren.