New Chemicals 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 proposed 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
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.
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 website (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. Several certificate notification categories are available as follows:
Standard Notification (STD) 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 (LTD) These are required for all new industrial chemicals and biopolymers where the volume of introduction is less than 1,000 kg/year (or 10 tonne/year in the event that they are manufactured in Australia, solely for the purpose of further manufacture at the same site) and new synthetic polymers with a NAMW greater than 1,000 daltons. Data requirements are less than for a standard notification (includes chemical identity, physico-chemical 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 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 (EXT) 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.
Self assessment (SAPLC/SANHC/SANHP) 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 (SAPLC) and Non-hazardous chemicals (SANHC) and non-hazardous polymers (SANHP) other than PLC. The holder of a self-assessment certificate must keep relevant records and report to the Director annually.
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. Several permit categories are available as follows:
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.
Export only permit (EOP) NEW Industrial chemicals introduced under the following scenarios will be eligible for the new Controlled Use Permits (Export Only):
o importation of a new chemical into Australia for export of entire quantity; or importation of a new chemical into Australia for use in formulation of products for export of entire quantity; or manufacture of a new chemical in Australia for export of entire quantity, or
o manufacture of a new chemical in Australia for use in formulation of products for export of entire quantity.
The Controlled Use Permit (Export Only) will be available for chemicals where low risk can be demonstrated.
Early Introduction Permit for Non Hazardous Chemicals (EIP) Applications for an EIP permit must be made in conjunction with an application for a certificate. 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.
Exemptions - NEW Some low regulatory concern chemicals are exempt from notification to NICNAS even if they are new industrial chemicals. Chemicals suitable to be introduced under an exemption are as follows:
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.
Low volume/other exemptions New industrial chemicals are exempt from notification if introduced:
o 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.
o 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
o in a cosmetic product at a concentration at 1% or less, and is non hazardous
o 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
o 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 these exemption categories, 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.
Annual Reporting - NEW Under section 21AA of the Act, introducers of chemicals eligible for these exemptions are required to report the name and quantity of these chemicals introduced at the end of every registration year. Additionally, NICNAS requires written advice from introducers of new cosmetic chemicals introduced under an exemption at greater than one per cent and 10 kilograms per annum. Introducers who are importing or manufacturing new chemicals under a low volume chemical permit, a commercial evaluation permit, a controlled use permit or a self-assessed assessment certificate are also required under section 40N to provide the name and quantity of any chemicals introduced under these permits/certificates and also report on any adverse effect on occupational health and safety, public health or the environment of which the person has become aware during the year.