Last update 30 November 2016
Data requirements for notification of new chemicals
Schedule A - STD or LTD notification general information
This part of the schedule specifies the set of information (including identification of data requirements, health and environmental effects, how the chemical meets hazardous substance definition and overseas notification of the chemical) that you must submit as part of your Standard or Limited notification application.
Schedule B - STD or LTD notification core information
This part of the schedule specifies the core set of information (including chemical identity, use and exposure details, and physico-chemical properties) that you must submit as part of your Standard or Limited notification application.
Schedule C - STD notification health and environmental effects
This part of the schedule specifies the health and environmental effects data you must submit as part of your Standard Notification application.
Schedule D - Polymers
This part of the schedule covers polymers. The numbering used is consistent with the numbering in the schedule to the Act.
Schedule E - Cosmetic ultraviolet filters
This part of the schedule provides details of additional data required for new industrial chemicals that are to be used as an ultraviolet filter in a cosmetic to be applied to the skin.
Data requirements for new PFCs and nanomaterials
New chemicals containing a perfluorinated carbon chain
This section contains an action plan for assessment and management of chemicals which may degrade to perfluorinated carboxylic acids (PFCAs), perfluoroalkylsulfonates (PFASs), and similar chemicals.
New industrial nanomaterials
As of 1 January 2011, a new industrial chemical that falls under the working definition of an 'industrial nanomaterial' is not permitted to be introduced under some exemption and self-assessment categories.
Variation to data requirements
If you consider a specified test or data item to be irrelevant, unnecessary or scientifically inappropriate in evaluating the potential occupational health, public health and environmental hazards of the chemical you can omit it, as long as you justify the omission under the appropriate item heading.
Examples may include, provision of a data item being scientifically inappropriate, not technically possible or not economically feasible. NICNAS can allow the variation or recommend that you substitute certain alternative data items.
Examples of variations to data requirements:
- If the chemical is a gas at room temperature, a feeding study cannot be carried out.
- An eye irritation test may be unnecessary for chemicals with a pH above 11.5 or below 2 as irritant effects are assumed.
- If data show that the chemical is a skin sensitiser in humans, then a skin sensitisation test in animals is not required.
- Acute inhalation toxicity results are not required if the chemical:
- has a vapour pressure <1.5 kPa
- as introduced has <25% of particles having <10 μm diameter
- is not purposely atomised during use (except where this constitutes a 'controlled' use).
You must fully justify omissions in data based on economic grounds if you consider or believe that:
- generating a particular data item required by the schedule is not economically feasible
- the data item is not essential for adequate occupational health and safety, public health and environmental assessment of the chemical
- the cost of generating the data may prohibit the introduction of the chemical
- the omission will not affect the preparation of an adequate assessment.
NICNAS will not consider claims for omitting data based solely on the administrative costs associated with preparing a submission.