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Information Requirements for Assessment

The Act contains a schedule of the information required for assessment of a chemical, split into parts A, B, C, D and E. Items listed in the schedule include:

  • Identity and use;
  • Physico-chemical properties;
  • Toxicological data;
  • Exposure information;
  • Storage and disposal; and
  • Material safety data sheet (MSDS) and label.

Data supplied is used to compile the assessment report for a certificate or to determine the conditions for a permit, so the data package must contain sufficient information to enable NICNAS to:

  • Confirm the chemical identity; and
  • Conduct occupational health and safety, public health and environmental risk assessments.

Applicant(s) unable to provide certain data items should apply for a variation of schedule data requirements, giving scientific reasons for the lack of data. Sufficient information must be available for NICNAS to perform an assessment of the chemical, and notifier(s) may be able to provide missing data for a structurally similar chemical analogue. If necessary, notifier(s) may need to conduct new studies.

 

Data Requirements

 

Details and guidance for data requirements are given in Appendix 12 of NICNAS Handbook for Notifiers and on the Forms pages (STD, LTD, PLC etc). In summary they are:

Category Data to be submitted
  Non Polymers Polymers
PLC N/A As per Form 1-PLC
SAPLC N/A As per Form 1-PLC Self Assessment
CEC A* (Para 2), B* (Paras 6a, 7, 8, 11, 12)
LVC A* (Para 2), B* (Paras 1, 3, 6, 7, 8, 11, 12)
EOP As per Form EOP-1
LTD A B A B D
STD A B C (and E*) A B C D (and E*)
SANHC As per Form 1-Self-Assessment Non PLC
SANHP As per Form 1-Self-Assessment Non PLC

*If the chemical is to be used as an ultraviolet filter in a cosmetic to be applied to the skin

Data Requirements for Perfluorinated New Chemiclas

Information Requirements for Perfluorinated New Chemicals
(PDF 100KB)

Amendments to the Schedule to the Act

 

The amendments to the Schedule (effective 27 September 2011) provide for the following assessment-related matters for new chemical notifications:

  • More appropriate information on the quantity of the chemical to be introduced into Australia;
  • More specific requirements on how the public at large is exposed to the chemical
  • Internationally aligned testing requirements for physical properties and toxicity.

 

The amendments align Australia’s data requirements with international best practice and provide greater certainty to applicants of new chemicals. For details see, Amendments to the Schedule

Material safety data sheet (MSDS) and label

 

MSDSs for the chemical, and products containing the chemical, and whether or not the chemical or products are hazardous substances, need to be included. NICNAS checks that the MSDS and label supplied conform to the National Occupational Health and Safety Commission (ASCC) codes of practice for labelling and for preparing an MSDS (refer www.ascc.gov.au).

 

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