New Chemicals

ASSESSMENT

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