A description of the various types of
assessments undertaken by NICNAS
is provided in Appendix 8.
Detailed statistics of new chemicals
assessment activity are provided
in Appendix 9.
In 2003-04, a total of 392 notifications
were received and accepted,
comprising 208 applications for certificates and 184 for
permits, an increase
of 16 and 12 per cent respectively from the previous year.
189 assessment certificates and published assessment reports for
chemical, an increase of 51 per cent from the previous year and
15 per cent
from 2001-02. A total of 151 new chemical permits were issued,
of 7 per cent from the previous year.
Trend analysis of assessments completed over the past 12 years
in Figure 5. The data demonstrate a sudden increase in completed
applications and a continued increase in permit applications.
Except for a decrease in 2001-02, the number of permit
steadily increased with time. A more cyclical increase and
been observed with the higher volume certificate applications,
a general fluctuation in business activity over the past decade.
NICNAS covers a wide variety of industries which manufacture and
industrial chemicals and the fluctuations cannot be linked to
The substantial increase in Standard notifications, double that
of last year,
has led to a high level of active certificate assessments
throughout the year.
Limited notifications were slightly decreased compared to the
however, the number of extensions remained similar to numbers in
years. The number of applications for extensions remains low,
poor utilisation of this option by industry. The number of PLC
continued to increase, up by 16 per cent from the previous year.
The number of permit applications was substantially higher in
the last quarter
of 2003-04. This has resulted in a substantially higher number
permit notifications at the conclusion of the business year. The
was for CEC applications, which were reduced from the previous
This reflected a change to the legislation in mid-2003 and,
allowable volume was increased for this permit category,
by NICNAS in use of the category by industry was also
In particular, no direct evaluation of a CEC chemical by the
retail sale can occur. The number of LVC applications continued
with an increase of 32 per cent from 2002-03.
A summary of applications for each notification category in
of the number of certificates or permits received over a
is illustrated in Figure 6.
Sixty-one EIPs were issued in 2003-04, a substantial increase on
years. These account for 31 per cent of the certificate
(excluding extensions). This permit enables chemicals that are
substances or dangerous goods, and which meet certain
criteria, to be introduced and used while the assessment is
undertaken by NICNAS. Issue of these permits facilitated the
of ‘safer’ chemicals whose entry into the marketplace would
been delayed until completion of the full assessment.
Five-year trend data for industry utilisation of EIP shown in
demonstrates a sustained trend of about one third of certificate
assessments preceded by an EIP. The trend indicates that there
no increase in the level of safer technology despite incentives
to do so.
Less than 10 kg per year exemption notifications remained
steady, with 398
applications for cosmetic chemicals, compared to 388 for
the ongoing trend towards the introduction of new chemicals at
volumes. Unlike cosmetic chemicals, notification for
(introduced at <10 kg/year) is not a statutory requirement and
under-reported to NICNAS; only 19 chemicals were reported in
in 2003-04. Figure 8 shows three-year trend data for use of the
<10 kg per
year exemption system with NICNAS.
The number of certificate chemicals notified (either
or PLC categories) since 2000-01 broken down into OECD
categories, is shown in Table 5.
As reflected in the three-year trend data shown in Table 5,
is again the highest use category with an increased number of
chemicals to last year. A significant increase was noted in
for printing/photocopying chemicals, with chemicals used in
the other strong contributor to the use pattern of newly
In 2003-04, NICNAS considered 15 applications for listing on the
section of AICS. This was a decrease of 11.8 per cent from the
year. In considering the case for confidential listing, the
Director must weigh
the commercial interest against the public interest. NICNAS has
group of technical experts, the Technical Advisory Group, to
in this process (see Appendix 10).
The Director granted
confidential listing for all 15 chemicals. There are no
pending applications. The three-year trend in Confidential
is shown in Figure 9.
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New chemical assessment output performance against target
detailed in Appendix 9. Eighty-eight per cent of total
reports (165) were provided to notifiers within statutory
days), below the agreed target of 95 per cent. This was due to
substantial increase in notifications above budget estimates,
for the high-level Standard notifications. Figure 10 shows the
for timeliness for certificate assessments (90 days) over three
The drop-off in performance coincided with the substantial
in certificate notifications throughout 2003-04, but
particularly in Quarter 1.
This put pressure on available assessment resources and the lag
required to recruit new assessors resulted in delays in
assessment work. Performance against timeframes for all
certificates had returned to 100 per cent by June 2004.
An analysis of the delayed assessment reports revealed that 7
were 1-5 days
late, 6 were 6-10 days late and the remainder (9) were greater
than 10 days
late. Six of the late reports were covered by EIPs, which meant
clearance to introduce was not delayed. An additional two
delayed through late receipt of the agency report and another
complex assessment issues. The remainder were delayed through
management issues, partly derived from associated difficulties
in late 2002-
03. Agency performance is summarised in Appendix 12.
The efficiency rate for permits exceeded the 95 per cent target
with 98 per
cent of permits being issued within the agreed statutory and
timeframes. Figure 11 shows the trend data for timeliness for
Both NICNAS and industry have statutory
responsibilities with regard to
the publication of assessment reports. Applicants may vary the
report and have a 14-day timeframe to lodge an application for
outlining the reasons for change. Ten applications for
variations of the
assessment reports were received during the year, of which three
pending at 30 June 2004. All other variations were resolved
between NICNAS and the applicant, with no appeals made by
Applicants may also provide written consent to publish the
the application or simply allow the publication process to
proceed. If 28 days
have elapsed since NICNAS provided the assessment reports to the
and no response is received, NICNAS can publish the assessment
Industry performance over time against this timeframe is shown
in Figure 12.
48 per cent of notifiers responded within the 14-day
timeframe, a significant decrease from the previous year. A
further 25 per
cent responded prior to the 28-day deadline for publication.
Less than 28
per cent did not respond to NICNAS, triggering the publication
to proceed after the 28-day deadline.
NICNAS issued 87 per cent of certificates within the 7-day
timeframe. Twenty-five certificates did not meet this timeframe,
delays ranging from one to twelve days. Performance gradually
in this area with only two delays of four and five days in the
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At the completion of the 2003-04 financial year, new chemical
output was slightly less than input. NICNAS received 208
notifications in the
certificate categories and issued 189 certificates in 2003-04.
This result was
due to the increased number of certificate notifications during
A similar position existed for permit applications, where the
was greater than output (162), largely due to a surge in low
chemical permit applications in June 2004. Table 6 details input
for certificate and permit categories for the past four years.
The number of active applications within the certificate and
categories is indicative of the input:output ratio; however, the
be significantly affected by the date of application. For
example, the high
number of active permit notifications at the end of 2003-04 was
the high number of permit applications in June 2004. Overall,
inputs will be
higher than outputs due to withdrawals by applicants and refusal
of some applications, for example, EIPs.
Efficiency gains were
made by increased use by industry of the New
Template for New Chemicals Notifications and extension of the
to PLCs, particularly the self-assessment option (see summary of
NICNAS also has available an electronic format for the
submission of CEC
and LVC permits. The use of this format is highly encouraged as
designed to deliver efficiencies to both industry and NICNAS in
ease of notification, reduction in assessment time and
compilation of internal
file notes, respectively. This initiative has grown in
acceptance by industry,
with 94 permit applications (76 per cent) received in electronic
in 2003-04, up from 21 per cent in 2002-03.
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Chemical notifiers and/or their consultants met with NICNAS
staff on 23
separate occasions throughout the year to take advantage of
free consultancy services. Such consultations are part of our
commitment to improve the quality of applications, and the
between NICNAS and our clients, as well as optimising assessment
timeframes through the lodgment of more complete notifications.
encourages notifiers to meet with staff at any time during the
process to discuss issues arising. Numerous other consultations
conducted by telephone or electronically.
Of the applications for certificates received in 2003-04, the
commenced on the day of receipt for approximately 35 per cent of
notifications, reflecting either a complete data package or one
minor deficiencies were identified. Of the remaining
applications, the clock
was not activated on receipt of application and/or the clock was
way through the assessment process and re-started. Flow through
illustrated in Table 7, indicate the Extension and Limited
categories to be the most successful in meeting the data
with 50 and 40 per cent respectively, beginning on the date of
Commercial evaluation permit and standard notification
the most deficient categories with only 25 per cent beginning on
of receipt. These data will allow better-targeted training
for industry in an effort to improve the quality of applications
of MSDS and labels for notified chemicals and products
containing the chemical remains an important part of the
process for all categories. In 2003-04, at least 600 MSDS were
by NICNAS on behalf of the chemical industry, helping to ensure
accurate and relevant information is available to workers,
and the community.
No new chemicals assessment decisions were appealed in
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At least 415 chemicals were introduced under the low volume < 10
category in 2003-04. Before provisions for low volume exemptions
introduced in 1999, these chemicals required notification prior
introduction. Estimates on the saving to industry in assessment
in 2003-04 if priced as low volume permits is approximately $1M.
(This estimate does not include the savings related to data
or industry administration costs.)
Overall, since introduction in 1997, this exemption category
provided access to chemicals on 1,768 occasions over seven years
a minimum potential saving to industry of approximately $4.7M.
introduced for non-cosmetic use under this category and
research and development introduced at < 50 kg/12 months do not
notification to NICNAS. Further, the continued increase in PLC
reflects the expansion of this category and the potential for
to be notified at lower cost and requiring less data.