Industrial Chemical Approval in Australia 

by David Chambers, July 2020

 

Introduction

Chemicals within Australia are regulated under a number of schemes and if a chemical is not for a therapeutic, agricultural, veterinary or food use, it is by default, considered to be an industrial chemical.

Australia’s industrial chemical regulation scheme, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), is being replaced by a new system known as, the Australian Industrial Chemicals Introduction Scheme (AICIS).  It is hoped that processes under the new system will make regulatory effort more proportionate to risk, promote safer innovation by encouraging the introduction of lower risk chemicals and will greater protect the Australian people and the environment from any harmful effects of industrial chemicals.

This change in the industrial chemical regulatory scheme from NICNAS to AICIS has occurred from 1st of July 2020. Underpinning the change is the Industrial Chemicals Act 2019, which will be supported by the Industrial Chemicals Rules and Industrial Chemicals Categorisation Guidelines, which together set out technical and operational details of the new scheme and the requirements introducers need to meet to categorise their chemicals. In addition, transition rules have also been established to manage the changeover from the old scheme to the new system.

 

Regulation

Whether they are imported or developed here, and barring a few very low risk exceptions, new chemical entities introduced into Australia need to be approved and registered by the Australian Government.  This applies to chemicals that can be used for a variety of purposes including;

·       Agricultural and Veterinary

·       Therapeutic

·       Cosmetic

·       Food Chemicals

·       Industrial

 

Regulation of the chemicals in each of these groups falls to the relevant authorized agency and the table below shows which agency is responsible for the regulation of each chemical category.

 

CATEGORY

REGULATING AGENCY

Industrial

Australian Industrial Chemicals Introduction Scheme

Agricultural and Veterinary

Australian Pesticides and Veterinary Medicines Authority

Therapeutic

Therapeutic Goods Administration

Cosmetic

Australian Industrial Chemicals Introduction Scheme

Food Chemicals

Food Standards Australia and New Zealand


 

What is Changing

The new scheme is the result of a reform process to improve the regulation of industrial chemicals in Australia. The main purpose of the new scheme will be to help protect the Australian people and the environment by assessing the risks of industrial chemicals and providing information and recommendations to promote their safe use.  Key changes are summarized in the following table.

 

CHANGE

DETAIL

Regulatory effort will be based on the likely risk of a chemical introduction

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

Focus our pre-introduction assessment on higher risk chemical introductions

Increased focus on post-introduction evaluation and monitoring

Lower risk chemical introductions will have streamlined introduction pathways

Incentive to introduce greener, safer new industrial chemicals

Reduced costs to businesses and consumers using lower risk chemicals

Reductions in the time taken to introduce the chemicals to market

Improved protections for Higher risk chemicals 

Regulators ability to impose conditions of introduction on higher risk chemicals

Power to refuse to allow introduction of the chemical or stop its introduction

Greater use of international assessment materials

A streamlined introduction pathway for introductions that have been assessed by a trusted international body.

Improved monitoring and compliance

New compliance powers, with civil and criminal penalties for breaches

Improved approaches to reviewing chemicals on the market

Installing a more responsive and flexible evaluation process

Greater transparency by striking a balance between confidentiality and publicly available information.

Publication of more meaningful information about assessments and evaluations

Restricting the use of animal test data for supporting the introduction of ingredients used in cosmetics.

Banning the use of animal test data generated after 1 July 2020 for supporting the categorisation or assessment of chemicals used solely in cosmetics

 

 

6 New Categories of Introduction

There are to be six new categories of  chemical introduction under the new AICIS scheme.  This will allow for greater flexibility and less regulatory effort. 

For example, a chemical introducer may eventually  desire to have a chemical listed on the AIIC inventory, but the chemical is not yet at commercial quality or volume.  In this case the introducer may apply for an assessment certificate for chemical introductions meeting Exempted or Reported criteria.

Those chemicals already registered on the old NICNAS database will not have to reregister on the new system since registrations will automatically roll over to the new system.

The 6 categories are; 

1.      Listed introductions (the chemical is listed on the Inventory and introduction is within the terms of the listing (if any)

2.      Exempted introductions (very low risk)

3.      Reported introductions (low risk)

4.      Assessed introductions (medium to high risk)

5.      Commercial evaluation introductions (for testing the market viability of the chemical before full introduction)

6.      Exceptional circumstances introductions (Ministerial authorisation to allow urgent introduction to protect public health or the environment).

 


 

What May Not Be Registered

There are some classes of chemicals that are prohibited from registration in Australia.  Some examples of these could be those that are too dangerous to use such as all forms of asbestos  and polychlorinated biphenyls (PCB’s).  Other chemicals like precursors to illicit drugs or those with a security impact such as materials that could be used as weapons, may also be restricted or prohibited. 

It should be noted that there does not exist a single list of prohibited or restricted chemicals and only approved chemicals will appear on the AIIC inventory list.  Therefore,  an industrial chemical that does not appear on the AIIC inventory, should be considered as not (yet) approved for introduction in Australia.

 

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