Types and Categories of NICNAS Assessments

New Chemicals: Industrial chemicals and polymers not listed in AICS

New Chemicals

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. 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

Certificates New chemicals 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 and in some cases after assessment, the chemical is listed on 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, State and Territory 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 web site (www.nicnas.gov.au) and may be used by State and Territory 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 Commonwealth 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 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, Material Safety Data Sheet (MSDS) and label.

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 polymers with a NAMW greater than 1,000 daltons. Standard data requirements are less than for a standard notification (includes chemical identity, physicochemical properties, use pattern, occupational, environmental and public exposure, MSDS and label), however, all available data must be provided.

Polymers of Low Concern (PLC) These chemicals are defined by predetermined criteria to be of Concern (PLC) 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 label. Customer agreements must be provided for each proposed user of the chemical. Annual reporting obligations apply*.

Low Volume Chemicals (LVC) LVCs are available for chemicals introduced at 100 kg/year Data requirements include health and environmental effects information, chemical identity, use, volume and duration of introduction, occupational, environmental and public exposure, MSDS and label. The maximum LVC permit period is three years, with the provision for unlimited renewal. Annual reporting obligations apply*.

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.

Research, development or analytical (RD&A) purposes RD&A chemicals that are imported or manufactured in volumes not more than 100 kg/year do not require notification but are subject to annual reporting obligations*. 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 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.

Self assessment Audited self-assessment allows industry to self-assess low regulatory concern chemicals against specified criteria and provide an assessment report which is screened and adopted by NICNAS. This category is available for Polymer of Low Concern (PLC) and Non-hazardous chemicals and nonhazardous polymers other than PLC. The holder of a self assessment certificate must keep relevant records and report to the Director annually.

Low volume exemptions New industrial chemicals are exempt from notification if introduced: 1.  at a port or airport in Australia, remains subject to the control of customs      at the port or airport at all times and leaves Australia less than 30 days      after the day of introduction. 2.  in quantities of not more than 10 kg in a period of 12 months, is for      cosmetic use, poses no unreasonable risk to occupational health, public      health or the environment, and meets certain safeguards 3.  in a cosmetic product at a concentration at 1% or less, and is non      hazardous 4.  in quantities not exceeding 100 kg in a period of 12 months, is for      non-cosmetic use, and poses no unreasonable risk to occupational      health, public health 5.  in an amount that is greater than 10 kg but not exceeding 100kg in      a period of 12 months, is for cosmetic use, and poses no unreasonable      risk to occupational health, public health or the environment.

Note Introducers under the low volume exemption category, self assessment, and certain permits must keep in writing, for 5 years after the introduction, all information available to the person about occupational health and safety, public health matters and the environmental effects of the chemical. In addition, introducers of chemicals in this category should complete an annual report form and return it to NICNAS before or on 28 September of the following registration year.

Existing Chemicals: Chemicals already in use in Australia Assessments Assessments include screening assessments, PEC assessments (full, preliminary, and secondary), other assessments 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 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 included on the Candidate List 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 for safe use. 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. Hazard assessment 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.