Australia NICNAS - National Industrial Chemicals Notification and Assessment Scheme

The National Industrial Chemicals Notification and Assessment Scheme, known as NICNAS, was established in 1990 under the Industrial Chemicals (Notification and Assessment) Act 1989 with the purpose of protecting workers, the public and the environment from the harmful effects of industrial chemicals.

NICNAS assesses industrial chemicals that are new to Australia for their health and environmental effects before they are introduced to Australia. All new industrial chemicals (i.e. those not listed on AICS) must be notified to NICNAS and assessed prior to their import or manufacture in Australia unless they are exempt.

NICNAS also assesses some priority existing chemicals (PECs) that are already in use in Australia. Companies who introduce PECs to Australia shall also apply for the assessment. If you export chemicals to Australia, you shall check if they contain any new substances or PECs first.

Scope of NICNAS

NICNAS excludes articles (such as plastic chairs and photographic film) and radioactive chemicals. Chemicals that are used solely as medicines, pesticides, veterinary chemicals, food or food additives are not regarded as industrial chemicals and are outside the scope of NICNAS. For a mixture (i.e., cosmetic), NICNAS applies to individual substances in it.

Main Requirements of NICNAS

Requirements	Notes
Business Registration	All importers and/or manufacturers of industrial chemicals for commercial purposes shall register themselves with NICNAS;
New Chemical Notification	A new chemical substance must be notified to NICNAS prior to its manufacture or import;
Annual Report	Annual reports need to be submitted for certain exempt or notified new chemical substances;
Assessment of Priority Existing Chemicals (PECs)	A person must not introduce a priority existing chemical unless an assessment certificate has been applied for;

NICNAS Registration of Businesses

All importers and/or manufacturers of industrial chemicals for commercial purposes are required to register with NICNAS regardless of the amount of industrial chemicals imported and/or manufactured in that registration year. The registration year runs from 1 September to 31 August in the following year. Please be noted that this is business registration, not substance or product registration.

Registration involves paying an annual registration fee and a registration charge, which varies according to the value of the chemicals manufactured or imported.

New Chemical Notification under NICNAS and Exemptions

A new chemical substance is an industrial chemical that is not listed on the Australian Inventory of Chemical Substances (AICS), or is a listed chemical substance subject to a condition of use. Only domestic manufacturers and importers can submit new substance notifications to NICNAS.

The following new chemical substances are exempt from notification and assessment:

• Manufactured in Australia in the course of a program of research, development and analysis (advice of introduction needs to be submitted to NICNAS);
• Imported to Australia solely for research, development and analysis with quantity less than <100kg/y (*);
• At ports subject to the control of Customs (max 30 days) *;
• Posing no unreasonable risk and quantity less than <100kg/y (*);
• Non-hazardous and introduced in a cosmetic with a concentration less than 1% (*);
• (*): Annual report is required ;

The picture below shows how to determine if a new chemical substance requires notification under NICNAS.

Types of Approvals for New Chemical Substances

For those new substances which do not qualify for exemptions, you may apply for two different types of approvals: certificates or permits. The table below summarizes different types of certificates or permits you can apply for a new chemical substance.

Commercial Evaluation Permit (CEP)	For test market purpose; Limited to 4 tonnes and 2 years;
Low Volume Permit (LVP)	<100kg/y new chemical; or <1000kg/y new chemical (must meet low hazard criteria);
Controlled Use Permit (CUP)	A low-risk new chemical because its use, handling and disposal are highly controlled; Limited to certain uses(i.e., export-only);
Polymer of Low Concern (PLC) Certificate	For new polymers meeting PLC criteria; No volume limit;
Limited Notification Certificate (LTD)	small-volume chemicals, biopolymers, and low MW synthetic polymers (NAMW <1000 Da)<=1t/y; or site-limited chemicals, biopolymers, and low MW synthetic polymers (NAMW <1000 Da)<=10t/y; or Synthetic polymers with NAMW >1000 Da that do not meet the PLC criteria; Reduced data requirements.
Standard Notification Certificate (STD)	For >=1t/y new chemicals that do not fulfill the requirements of any other categories above;
Early Introduction Permit (EIP)	Allowing notifiers who have submitted PLC, LTD or STD to introduce a new chemical substance before NICNAS assessment is completed; The new chemical must meet certain prescribed criteria; Permit gets expired when a certificate is issued.

Detailed data requirements for new chemical notification can be found here. The picture below given by NICNAS compares the differences between a certificate and a permit.

Self-assessment vs Non-self-assessment

For PLCs or non-hazardous substances (substances of low regulatory concern), a notifier can self-assess them against specified criteria and provide an assessment report which is screened and amended by NICNAS in consultation with the notifier before publication. The self-assessment time frame (28 days) is much shorter than for non-self-assessment category (90 days). Fee is also lower. In this case, annual report is required.

Annual Report

A person who introduces a new industrial chemical in a registration year under circumstances 1 to 8 (see picture 1) must provide a report to NICNAS stating the name of the chemical, its volume and adverse effects found. The report must be provided before or on 28 September of the following year.

Priority Existing Chemicals (PECs)

A PEC is an industrial chemical for which NICNAS requires investigation in detail because of its potential risks to human health or the environment. A person must not introduce a priority existing chemical to Australia unless an assessment certificate has been applied for.

Where a chemical becomes a priority existing chemical, a person may, within 28 days, apply in writing for the assessment of the chemical. Where the chemical has been a priority existing chemical for longer than 28 days, the person may make a late application. If no application is lodged after a chemical is declared a PEC, the NICNAS Director can request an assessment report be started at any time within 12 months.

The Director may also require relevant persons to supply information required for the PEC assessment. Required info includes hazard properties, test reports, volume, uses, info on downstream users and conditions related to manufacture, handling and storage.

From July 2012, NICNAS began assessing around 3,000 priority existing chemicals. In addition to that, NICNAS has drawn up a candidate list of chemicals to consider declaring as PECs. You can find out if an existing chemical substance is a PEC or candidate PEC or not on AICS.

NICNAS Assessment Reports

If a notification is made under a certificate category, an assessment report will be published on NICNAS's website containing a summary of health, safety and environmental matters considered in the assessment and such recommendations as may reasonably be made to ensure safe use of the chemical. These reports can be access here.

Related Regulations and Standards

• Work Health and Safety Regulations (WHS Regulations) and GHS;