Type of assessment

Last update 30 November 2016

Once you have established you need to notify NICNAS of the new chemical you intend to import or manufacture (excluding a chemical introduced under exemption), you determine the most appropriate notification category.

Two broad categories exist for assessing a new chemical—permits and assessment certificates. To decide which to use, you need to consider:

  • type of chemical
  • amount you are introducing
  • use of the chemical
  • period of use
  • your company's business needs and commitments.

Permit application

You will need to apply for a permit for new chemicals which meet certain criteria. Having a permit essentially means:

  • you are allowed to introduce fixed quantities of the chemical for the permit duration
  • a notice of the permit will be published in the Chemical Gazette
  • the chemical will not be added to the Australian Inventory of Chemical Substances (AICS)
  • a shorter assessment time and lower fees than for assessment certificates (see table below)
  • you can renew your existing permit in certain circumstances (see Renewal of permits)
  • for CUP, CEC and LVC permits, you will need to submit annual reports at the end of the registration year.

Assessment certificate

You will need to apply for an assessment certificate for chemicals that do not meet the permit criteria or where you prefer a certificate notification resulting in listing the chemical on the AICS.

There are two types: self-assessment and non self-assessment.

Having an assessment certificate essentially means:

  • you are allowed to introduce the chemical
  • brief facts about the identity of the notifier, and chemical's identity and key hazard, volume and use information on the chemical will be published in the Chemical Gazette and a public report will be made available on this website
  • the chemical will eventually be added to the AICS.

Table: Comparison of permits and certificates

Certificate

Permit

Assessment certificate issued

Permit issued with conditions stipulated, including duration and volume

Data requirements as per category

Reduced data requirements

Eventual listing on the AICS

No eventual listing on the AICS

Publication of a risk assessment report (with recommendations) on the NICNAS website

Publication of notice in the Chemical Gazette with summary details

Statutory timelines: 29–90 days

Shorter statutory timelines: 14–28 days

Higher cost

Reduced cost


New chemical notification categories

The following table summarises all new chemical notification categories, providing information on outcome based on the chemical amount introduced. It also lists the duration of the certificate or permit and the assessment time frame.

Table:  Summary of all new chemical notification categories

 

Outcome

Chemical amount introduced

Duration of certificate or permit

Assessment timeframe

Permits

Commercial evaluation chemical (CEC)

Permit

<4 tonnes

Up to 2 years

Usually within 14 days

Low volume chemical (LVC)

Permit

<100 kg/yr

3 years

20 days

Low volume chemical (LVC)

Permit

>100 but ≤1000 kg/yr1

3 years

20 days

Controlled use permit (CUP)

Permit

Unlimited

3 years

Usually within
28 days

Controlled use—Export only permit (EOP)

Permit

Unlimited

3 years

Usually within 20 days

Early introduction permit (EIP)—this category accompanies Polymer of low concern (PLC), Limited (LTD) or Standard (STD)

Permit

As for PLC, LTD or STD

Until certificate issued, or permit rescinded

28 days

Permit renewal

Permit

As for previous LVC, CEC, CUP, EOP

3 years (LVC/CUP/EOP) and up to 2 years (CEC)

20 days (LVC/EOP), and usually 28 days (CUP) and 14 days (CEC)

Certificates

Polymer of low concern (PLC)2

Certificate

Unlimited

5 years

90 days

Limited (LTD)2

Certificate

<1 tonne/yr3

<10 tonne/yr3 for site limited chemicals

5 years

90 days

Standard (STD)2

Certificate

>1 tonne/yr

5 years

90 days

Self assessment4

Certificate

As for PLC, LTD or STD

5 years

28 days

Extension of an original assessment certificate (EX)

Certificate

As for PLC, LTD or STD

5 years from granting of original certificate

45 days

1 Low hazardous criteria apply

2 For STD, LTD and PLC, there are modular notification categories available, with reduced fees, where:

  • Similar chemical: the notified chemical or polymer is similar to a chemical or polymer previously assessed by NICNAS, or
  • Group Assessment: the notified chemical or polymer is being notified at the same time as a similar chemical or polymer , and for a similar use, or
  • Approved Foreign Scheme: an assessment of the notified chemical in Canada (under a comparable schedule) is available, or
  • Comparable Agency: an assessment of the notified chemical by:
    • the Therapeutic Goods Administration (TGA), the Australian Pesticides and Veterinary Medicines Authority (APVMA) or Food Standards Australia New Zealand (FSANZ) is available, or
    • a chemicals notification and assessment scheme from the USA, EU (pre-REACH), Canada (where the criteria for the Approved Foreign Scheme category are not met) or OECD member country is available.

See Modular notification categories and Use of overseas assessments in the notification of new chemicals for more details.

3 Volume restriction does not apply to synthetic polymers with NAMW >1000 Da.

4Nanomaterials are not eligible for this certificate category.


Forms and fees

Forms and checklists referred to can be downloaded from the forms page and fees and charges can be found here.

Note: All permit applications result in the issuing of a permit and publication of a notice in the Chemical Gazette.