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Ammendments to the Schedule

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.

Changes to general data requirements for new chemicals

 

The Schedule stipulates the data that must be provided for new chemical notifications. The amendments, along with comments regarding the impact of each amendment for notifiers are outlined in the table below.

TABLE

 

Relevant Schedule Part Previous Schedule Item Amended Schedule Item Comment
Part B
Clause 4
The appearance, being the colour and form, of the chemical at 20° Celsius and 101.3 kPa The physical state and appearance (being the colour and form) of the chemical at 20° Celsius and 101.3 kPa This amendment reflects the current practice that the majority of notifiers provide this information, and that the physical state is helpful in estimating exposure and therefore the risk to health, safety and the environment.
Part B
Clause 5
The quantity, in a range of tonnes per year The estimated quantity, in tonnes per year, or, in a range of tonnes per year This amendment allows for a more accurate measure of the introduction volume to be provided, which will assist in the risk assessment. The ability to provide the estimated volume as a range has been retained where an accurate measure is not possible.
Part B
Clause 6(a)(i)
The number and category of workers to be involved in working with the chemical The category of workers to be involved in working with the chemical This amendment reflects current practice where it is often difficult for a notifier to estimate numbers of exposed workers for a chemical yet to be introduced.
Part B
Clause 8
A brief description of any way in which the chemical could be harmful or hazardous to the health of the public at large. A description of the ways in which the public might be exposed to the chemical based on its proposed uses and its potential release in the environment This amendment, in essence, reflects the information that is currently provided by notifiers and for the majority of notifiers (particularly those that complete template notification forms), and will result in no changes to the current practices. 1
Part B
Clause 9(m)(i)
The degree of the chemical’s flammability, including:
(i) the upper and lower limits of flammability in air;
The degree of the chemical’s flammability, including:
(i) for gases and vapours the upper and lower limits of flammability in air;
(ia) for solids - the ability to propagate combustions;
This amendment clarifies the data requirements with respect to the physical state of chemicals, and is designed to make NICNAS requirements more consistent with hazard classification requirements and international test protocols.
Part B
Clause 9(p)
Information about the chemical’s potential (if any) to detonate as the result of heat, shock or friction; The chemical’s explosive properties, including the chemical’s potential (if any) to detonate as the result of heat, shock or friction; This amendment clarifies this data item and is designed to make NICNAS requirements more consistent with hazard classification requirements and international test protocols.
Part B
Clause 9(q)(i)
information about the stability and reactivity of the chemical including:
(i) particulars of conditions constituting the chemical’s instability;
information about the stability and reactivity of the chemical including:
(i) particulars of conditions constituting the chemical’s instability; and
(ia) the chemical’s oxidising properties;
This amendment is designed to make NICNAS requirements more consistent with hazard classification requirements and international test protocols.
Part C
Para. g
the toxic effects of the chemical on administration for a period of 10 to 14 days; the toxic effects of the chemical on administration for a period of 28 days; This amendment reflects the current global practice that short-term repeat dose toxicity studies tend to be conducted over 28 days rather than 10-14 days.
Part C
Para. j
any induction by the chemical of germ cell damage; any production by the chemical of genotoxic damage in a suitable in vivo test;

This change reflects the current practice where an in vivo study on the induction of germ cell damage is rarely available to notifiers. The requirement now allows for any suitable in vivo genotoxicity study to be submitted, and therefore allows for the more common in vivo micronucleus test (for example) to be used to fulfil this requirement.

 

Note that, as previously, this data requirement may be varied or omitted if there are suitable scientific grounds for doing so (such as negative outcomes in appropriately conducted in vitro studies).

Part D

Clause 4

The maximum weight percentage of low molecular weight species of the polymer below 1,000. The maximum weight percentage of low molecular weight species of the polymer below 500 daltons and below 1,000 daltons. This amendment reflects the current practice where both proportions are available from an analysis of the polymer, and also the fact that the proportion below 500 daltons is an important consideration for the risk assessment.

1 For guidance on completing this Schedule requirement, notifiers are encouraged to consult the Public Exposure Section within the following document: Guidance Document 1: STD and LTD Template

 

Notifiers are reminded that while new data requirements have been incorporated into the Schedule, it is possible to apply for a Variation to the Schedule Data Requirements under Section 24 of the Act.

 

NICNAS has updated new chemical notification forms and guidance documents to reflect the above changes. Therefore, to ensure that you are using the correct notification form, we recommend that you download the appropriate form each time you notify (i.e. do not complete/submit forms that have been previously downloaded and saved to your computer). The current (revised) notification forms can be obtained from the New Chemicals Forms page on the NICNAS website.

 

The NICNAS Handbook for Notifiers is currently being revised. The above amendments will be reflected in the revised handbook.

 

Addition of Schedule Part E for new UV filters applied to the skin

 

Under the cosmetics reforms in 2007, it was agreed that the data requirements for new UV filters which applied under the TGA be maintained when these chemicals are assessed by NICNAS. As some of the data required by TGA were not listed in the NICNAS Schedule to the Act, NICNAS needed to use its existing power to call for extra data whenever such chemicals were notified, resulting in uncertainty for business as to what data NICNAS requires to complete its assessment process. Under the changes to the Schedule to the Act, a new Part E to the Schedule has been inserted to cater for these requirements.

 

The new Part E requires data on the following for UV filters applied to the skin:

  1. the chemical’s photostability;
  2. the chemical’s phototoxicity;
  3. The chemical’s photosensitisation;
  4. the chemical’s bioavailability via the oral and dermal routes;
  5. the chemical’s toxic effects on administration for a period of 3 to 6 months, by the oral and dermal routes;
  6. the chemical’s photomutagenicity;
  7. the chemical’s toxic effects on reproduction, including toxicity to male fertility;
  8. the carcinogenic potential of the chemical, including photocarcinogenicity;
  9. the potential of the chemical to interact with another chemical used as an ultraviolet filter in a cosmetic to be applied to the skin;
  10. Beiing data obtained:
  11. by specified methods; and
  12. from specified raw data.

As with all notification statements, an application to vary the data requirements listed in the Schedule for UV filters can be made by application to the Director.

 

NICNAS has updated the new chemicals notification forms with these data requirement, and a guidance document relating to the data requirements for new UV filters is currently being prepared for incorporation into the revised Handbook for Notifiers. NICNAS will also regard these data as being basic information, that is, they cannot be exempted from publication in assessment reports, and this requirement will be reflected in the changes to the Regulations.

 

In the meantime, should you require further information, please contact the New Chemicals Program at NICNAS. Note that administrative changes need to be made to the Regulations in relation to UV filters in cosmetics applied to the skin, however theses regulation changes will not affect the data requirements detailed above.

 

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