Types and Categories of NICNAS Assessments

New Chemicals: Industrial chemicals and polymers not listed in AICS

Certificates

Chemicals not in AICS can only be introduced by the holder of an
assessment certificate (unless the chemical is covered by a permit
or under specific NICNAS exemptions). After five years, the chemical
is listed in AICS and is available for open use. The assessment report
is provided to the notifier, who is able to use the report to support their
responsibilities for control of the chemical, for example, States and
Territories hazardous substances legislation, environmental legislation
and Poisons Scheduling. The full public report, including recommendations
on safe use, is available to the public on the NICNAS website
(www.nicnas.gov.au) and may be used by States and Territories agencies
and in the workplace. Commercially sensitive information may be exempt
from publication in the full public report if the commercial interest outweighs
the public interest. Summary reports of each assessment are published
in the Chemical Gazette.

Standard Notification

Required for all new industrial chemicals and biopolymers where
the volume of introduction is greater than 1,000 kg/year, and new synthetic
polymers with a number-average molecular weight (NAMW) less than
1,000 daltons (except certain polyesters of low risk). This category requires
the highest level of data including toxicological and ecotoxicological test data,
chemical identity, physico-chemical properties, use pattern, occupational,
environmental and public exposure information, environmental fate data,
MSDS and labels.

Limited Notification

These are required for all new industrial chemicals and biopolymers
where the volume of introduction is less than 1,000 kg/year, and new
synthetic polymers with a NAMW greater than 1,000 daltons. Standard
data requirements are less than for a standard notification (includes
chemical identity, physico-chemical properties, use pattern, occupational,
environmental and public exposure, MSDS and labels); however, all available
data must be provided.

Polymers of Low of Concern (PLC)

These chemicals are defined by predetermined criteria to be low hazard
to humans and the environment. PLC can be introduced into Australia
with reduced fees and reduced data requirements.

Extension of Original Assessment Certificate

The original assessment certificate can be extended to include other
introducers, providing the original certificate holder agrees in writing.
In addition to specific data requirements, new information on exposure
or adverse health and environmental effects must also be provided.

Permits

Permits allow chemicals to be introduced conditionally, without a full
assessment, providing certain information is provided on identity, hazard
and exposure. MSDS and labels must also be provided. NICNAS assesses
permit applications under shorter timeframes and reduced fees.

Commercial Evaluation Category (CEC)

Chemicals to be introduced solely for determination of their commercial
potential are eligible for assessment as CECs. The application can be for
introduction of up to 4,000 kg for up to two years provided that the quantity
and timeframe requested by the notifier can be justified as necessary
for commercial evaluation purposes. Data requirements include health
and environmental effects information, chemical identity, use and distribution
arrangements, volume and duration of introduction, occupational,
environmental and public exposure, MSDS and labels. Customer
agreements must be provided for each proposed user of the chemical.

Low Volume Chemicals (LVC)

LVCs are available for chemicals introduced at 10-100 kg/year (nationwide
volume limit). Data requirements include health and environmental effects
information, chemical identity, use, volume and duration of introduction,
occupational, environmental and public exposure, MSDS and labels.
The maximum LVC permit period is three years, with provision for unlimited
renewal.

Early Introduction Permit for Non - Hazardous Chemicals (EIP)

EIPs are available for the introduction of non-hazardous chemicals with
respect to human health and the environment. Once an EIP is granted,
the applicant may introduce the chemical according to permit conditions
before the full assessment has been completed. Factors taken into account
include reasonable protection of occupational health, public health
and the environment.

Small volumes notification only – the <10 kg rule – cosmetic and
non-cosmetic chemicals

This provision allows for introduction of small volumes of new chemicals and
polymers provided certain criteria are met. The exemption does not apply
to chemicals that pose an unacceptable risk to occupational health, public
health or the environment. The introducer is responsible for conducting the
risk assessment. There are specific criteria for cosmetic chemicals,
incorporating safeguards for consumer use; for instance, a cosmetic
chemical must not be used as a preservative, a colouring agent or an
ultraviolet filter. In addition, the chemical must not be prohibited or restricted
for cosmetic use in either the European Union under directive 76/768/EEC
as amended, or the USA under the Food, Drugs and Cosmetics Act 1938
as amended. More information is required in relation to effects in high-risk
consumer groups consistent with the anticipated use of the cosmetic
product, if the chemical is present at greater than one per cent.

Research, development or analytical (RD&A) purposes

RD&A chemicals that are imported or manufactured in volumes less than 50
kg/year do not require notification. At higher volumes, the same provisions
apply as for other new chemicals and polymers. An exception applies in
certain specific cases where an RD&A chemical is manufactured in Australia
at greater than 50 kg/year in situations where smaller volumes cannot be
manufactured; for example, limitations on the size of equipment available
for manufacture. In these cases, information must be provided to NICNAS
on the type and location of the apparatus (a fixture), the program of work,
type of chemical, and procedures for safe disposal of the chemical and any
hazardous degradation products.

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Existing Chemicals: Chemicals already in use in Australia

Assessments

Assessments include screening assessments, PEC assessments (full,
preliminary, and secondary) and international assessments. PEC
assessments are comprised of assessment modules, with the modular
make-up of each assessment varying depending on the scope of the
assessment. The modules are: hazard assessment, exposure assessment,
risk assessment/current controls, environment assessment, public health
assessment, and recommendations/final draft report.

Screening Assessments

Candidate chemicals to be considered for full or preliminary assessment are
assessed by an expert agency panel against a set of criteria covering issues
in public health, occupational health and safety and the environment.
The data used for the screening comprise health and environmental hazard
data plus exposure data submitted by industry in response to notice in the
Chemical Gazette. Screening allows the chemicals to be ranked on the basis
of the perceived severity of the threat posed to human health
or the environment. Results of screening assessments are made public.

Other Assessments

This class of assessment provides for the fast collection and distribution
of data on one or more aspects of a chemical that may be of concern, but
which has not been declared a PEC. They serve the situation where there
is an identified need for data on a chemical, but not necessarily for an
evaluation of the data. Related or similar chemicals may be considered as a
group. The draft reports are circulated for comment to interested parties
before publication.

Full Assessments

Full assessments usually include information on chemical and physical
properties, uses, exposure, kinetics and metabolism, effects on experimental
animals and in vitro test systems, and human health effects. They include a
hazard assessment and classification, a section on risk characterisation, risk
management, and recommendations. Full assessments include an
occupational, consumer and/or environmental risk assessment. Sometimes
related or similar chemicals are assessed as a group, and the assessment
can focus on specific areas of concern. This flexibility in assessment ensures
that NICNAS resources are targeted effectively to priority areas of concern.

Preliminary Assessments

Preliminary assessments are less detailed, tailored to the particular aspects
that are the focus of the assessment. Preliminary assessments do not
include a risk assessment. As with full assessments, preliminary
assessments can apply to the chemical generally, or can focus on particular
uses of the chemical, or on its manufacture, handling, storage or uses in a
specified geographical area or in specified circumstances.

Secondary Assessments

Following the publication of a PEC assessment there may be changes in
circumstances which necessitate a reassessment of particular aspects of the
chemical. The secondary notification and assessment process is
implemented when a new use of the chemical occurs or when significant
new information about the health or environmental effects or circumstances
of use of the chemical become available. Secondary assessments may also
be required for new chemicals that have been assessed by NICNAS.

International Assessment Programs - IPCS/CICADS; OECD - SIDS;

There are two international assessment programs for existing chemicals
under the auspices of the OECD and the IPCS. These programs coordinate
international agreements on one assessment of a chemical, based on a draft
assessment contributed by one of the participating countries, thereby
avoiding duplication of the assessment by the other participating countries.
The outcomes of international assessments are routinely considered by
NICNAS. IPCS is a cooperative program of the World Health Organisation
(WHO), the United Nations Environment Programme (UNEP) and the
International Labour Organization (ILO). Concise CICADs are published under
this program. They are summaries of relevant scientific information based on
selected national or regional evaluation documents.

The OECD SIDS program concentrates on the potential hazards of high
production volume chemicals (HPV), which are defined as chemicals being
produced in quantities of at least 1,000 tonnes per year in at least one OECD
member country. In order to share the burden of testing and assessing
these chemicals, member countries work together to cooperatively
investigate HPV chemicals. Reports prepared by a country are available
to all other member countries. The assessments are considered and
member countries agree on conclusions about the hazards of the chemical
and recommendations concerning the need for follow-up actions.
The chemical industry plays a significant voluntary role in this program.