1.1 GENERAL REQUIREMENTS
All new industrial chemicals must be
notified to NICNAS, and an assessment certificate or permit
obtained before they can be imported and/or manufactured in
Australia. Certain new industrial chemicals are considered
exempt from notifying to NICNAS but are subject to reporting
requirements.
A new industrial chemical means an
industrial chemical that is not a listed on the Australian
Inventory of Chemical Substances (AICS). Some chemicals
listed on the AICS may be subject to conditions of use under
section 13 of the Act. These chemicals are also defined as
new industrial chemicals if their use is for other than that
stated on AICS.
A chemical that is a reaction
intermediate* or an incidentally produced chemical* is not
considered a new industrial chemical.
Compliance Criteria
Evidence is required to demonstrate
whether the chemical or product imported and/or manufactured
is or contains a new industrial chemical. In the case of a
new industrial chemical, you must hold a valid assessment
certificate or permit for the new chemical.
There are other circumstances where you
may introduce an industrial chemical without holding an
assessment certificate of permit. For compliance guidance to
these cases, see the Exemptions Section.
Checklist
Have you checked that all
imported and manufactured industrial chemicals are listed on
AICS?
If the chemical is a new
industrial chemical, is it exempt from notification and
assessment requirements?
See the Exemptions Section
If the chemical is a new
industrial chemical, does the introducer hold a valid
assessment certificate or permit?
* See Definitions
1.2 EXEMPTIONS
There are certain circumstances where
you may import and/or manufacture a chemical without holding
an assessment certificate or permit. In these cases, the
chemical may be introduced under a specific exemption
category as defined in the Act under Section 21.
Compliance Criteria
Relevant data are required to show that
the chemical is covered by a specific exemption under the
Act.
Where a specific exemption applies
(Section 2. to 4. below), you are required to provide a
report to the Director on an approved format stating the
name of the chemical and the quantity introduced. The report
must be provided before or on 28 September of the following
registration year. A registration year runs from 1 September
to 31 August.
The introducer of the new chemical must
provide an annual report detailing:
Checklist
1. New chemical introduced for
research, development or analysis
-
Manufactured in a fixed
apparatus in specific location
-
Imported and/or manufactured at
a maximum of 100 kg in any 12 months
2. New chemical intended for non
cosmetic* use and does not exceed 100 kg in any 12 months
3. New Chemical intended for
cosmetic* use
A new chemical used in cosmetics as a
preservative or colouring agent or an ultraviolet filter is
not exempt from notification and should not be introduced
under the exemption category.
-
Introduction volume does not
exceed 100 kg in any 12 months
-
The chemical is introduced
between 10 and 100 kg/annum:
-
The chemical is introduced at
less than 10 kg/annum:
-
Non hazardous and introduced at
less than 1%
4. New chemical introduced under
the transhipment category
1.3 PERMITS
Commercial Evaluation Chemical (CEC),
Low Volume Chemical (LVC) and Early Introduction Permits are
available for new chemicals introduced under the permit
category. Holders of the permit(s) must comply with the
stipulated conditions.
Compliance Criteria - all Permits
Evidence is required that the holder(s)
of the Permits are complying with the standard Permit
conditions, as well as any special conditions.
Holders of permits (CEC and LVC) are
required to provide a report to the Director stating the
name of the chemical and the quantity introduced. The report
must be provided before or on 28 September of the following
registration year. A registration year runs from 1 September
to 31 August.
Checklist
The report must be provided before or on
28 September of each registration year.
Are the workers handling the new
chemical aware that it is being introduced under a Permit
system, and what safety measures are in place?
How is the chemical disposed of?
Is there continuous monitoring
of the use and health and environmental effects of the
chemical?
1.3.1 Commercial Evaluation Chemical
Permits
Commercial Evaluation Chemical (CEC)
Permits are issued for new industrial chemicals to be
introduced solely for the purpose of commercial evaluation
where the maximum quantity to be introduced is 4000 kg in a
maximum period of two years.
Compliance Criteria - CEC Permits
Evidence is required that the holder(s)
of the Commercial Evaluation Permit are complying with the
Permit conditions.
Evidence is required that the annual
report was submitted to NICNAS.
Checklist
Was the chemical used only for
commercial evaluation, and what were the results?
The annual report is required by
the end of the registration year; however, the Final
Evaluation Report is required at the end of the permit
period.
Do all users of the chemical
have signed user agreements in place?
1.3.2 Low Volume Chemical Permits
Low Volume Chemical Permits (LVC) are
issued for new industrial chemicals to be introduced at a
maximum volume of 100 kg/year (1000 kg/year in certain
cases) for a period of 3 years.
Compliance Criteria - LVC Permits
Evidence is required that the holder(s)
of the Low Volume Chemical Permit are complying with the
Permit conditions.
Evidence is required that the permit
holder keeps records for up to 5 years and an annual report
is submitted to NICNAS.
Checklist
1.3.3 Early Introduction Permits
Application for an Early Introduction
Permit (EIP) can be made in conjunction with a Limited
(LTD), Standard (STD) or Polymer of Low Concern (PLC)
Notification. The holder of an EIP may commence introduction
of the chemical before the assessment is completed.
Compliance Criteria - Early
Introduction Permits
Evidence is required that the holder(s)
of the Early Introduction Permit are complying with the
Permit conditions.
Checklist
Were the volume and period of
introduction within the limits specified in the permit
conditions?
1.4 SELF ASSESSED ASSESSMENT
CERTIFICATE
A manufacturer and/or importer may apply
for a self-assessed assessment certificate for a polymer of
low concern; or any other chemical or class of chemical for
which the criteria are prescribed in the regulations.
Compliance Criteria
A person issued a self-assessed
assessment certificate must keep records to support any
statement made in or in connection with the application for
the certificate.
Records must be kept for 5 years.
The holder of the certificate must
provide an
annual report detailing:
-
the name of the chemical
-
the volume of the chemical introduced
during the year; and
-
any adverse effect of the chemical on
occupational health and safety, public health or the
environment of which the holder has become aware during
the year
The report must be provided before or on
28 September of the following registration year.
Checklist
Keeping of records relating to
application for self-assessed certificate
