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Department of Health and Ageing, Therapeutic Goods Administration (Australian government)


Report Title: Attachment 7: Proposed Model for a Mandatory Notification and Assessment
Report ID: 424
Date: 11/1/2009
Author: National Industrial Chemicals Assessment and Notification Scheme
Report Type: Background Document
URL: [Attachment_7_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: The following attachment contains a proposed model for the mandatory notification and assessment program as described in NICNAS’s Proposal for Regulatory Reform of Industrial Nanomaterials Public Discussion Paper.
Archived Copy: Attachment_7_PDF_424_2615.pdf



Report Title: Attachment 6: Proposed Strategy for Nano-forms of New-chemicals
Report ID: 423
Date: 11/1/2009
Author: National Industrial Chemicals Notification and Assessment Scheme
Report Type: Background Document
URL: [Attachment_6_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: The following attachment contains tables and drawings that illustrate the current regulatory framework for industrial nanomaterials in Australia. Elaborated, this consists of the provisions for new chemicals used in research and development under The Industrial Chemicals Notification and Assessment Act 1989, a summary of the permit categories for regulation of industrial nanomaterials under NICNAS, the proposal for regulation of industrial nanomaterials under NICNAS certificate categories, and a proposed strategy for requesting particle size distribution information for permit and certificate categories.
Archived Copy: Attachment_6_PDF_423_6363.pdf



Report Title: Attachment 5: Overview of NICNAS New Chemical Notification Categories
Report ID: 422
Date: 11/1/2009
Author: National Industrial Chemicals Notification and Assessment
Report Type: Background Document
URL: [Attachment_5_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: This attachment contains an overview of NICNAS two new chemical notification categories. The first, permit notification, is suitable for chemicals which meet certain criteria and result in the issue of a permit allowing the introduction of fixed quantities of the chemical for the duration of the permit. The certificate notification, which is the second, is intended for chemicals which do not meet the permit criteria or where the introducer prefers a certificate notification to a permit notification. Certificate categories result in an assessment report, the issue of an assessment certificate, and public publication of the assessed chemical. Additionally, a chemical that has been formally assessed by NICNAS, either as a new or existing chemical, may necessitate a secondary notification assessment due to changed circumstances. The procedure for such reassessment is set in place by Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989).
Archived Copy: Attachment_5_PDF_422_5015.pdf



Report Title: Attachment 4: Overview of International Activities Addressing Regulation of Industrial Nanomaterials
Report ID: 421
Date: 11/1/2009
Author: National Industrial Chemicals Notification and Assessment
Report Type: Background Document
URL: [Attachment_4_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: The following attachment contains overviews of the regulation of industrial nanomaterials from the United States, Canada, the United Kingdom, and the European Union’s REACH regulatory schema.
Archived Copy: Attachment_4_PDF_421_7062.pdf



Report Title: Attachment 3: Summary of Findings from Review of the Possible Impacts of Nanotechnology on Australia’s Regulatory Framework
Report ID: 420
Date: 11/1/2009
Author: National Industrial Chemicals Notification and Assessment Scheme
Report Type: Background Document
URL: [Attachment_3_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: Australia’s federal regulatory frameworks are generally well suited to allowing adequate management and control of risks posed by engineered nanomaterials (NM) and products incorporating NM, and their manufacture, use and handling. This review found that there was no case where a particular regulatory framework generally did not apply to a nanofamily as a result of the presence of NMs. Further, the application generally of the federal regulatory frameworks to NMs and products in the nanofamilies meant that regulation throughout the whole of the lifecycle of these materials is largely the same as for conventional products. However, the general repercussions of such applications were also the same as for conventional products; some regulatory regimes involve regulatory approval prior to undertaking the particular regulated activity. This, in tur, meant that steps not required to be taken under particular regulatory frameworks were also not taken for NMs. Nevertheless, some gaps were found where the regulatory frameworks either do not apply at all to NMs and products incorporating them or do not apply to NMs or nanoproducts as appropriately as they apply to conventional products in the same families.
Archived Copy: Attachment_3_PDF_420_2280.pdf



Report Title: Attachment 2 - Indicative List of Nanomaterials.
Report ID: 419
Date: 11/1/2009
Author: National Industrial Chemicals Notification and Assessment Scheme
Report Type: Background Document
URL: [Attachment_2_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: This attachment contains an indicative, but by no means exhaustive, list of substances that the National Industrial Chemicals Notification and Assessment Scheme considers to be produced as industrial nanomaterials.
Archived Copy: Attachment_2_PDF_419_9730.pdf



Report Title: Attachment 1: Overarching Principles of the NICNAS Regulatory Strategy
Report ID: 418
Date: 11/1/2009
Author: National Industrial Chemicals Notification and Assessment Scheme
Report Type: Background Document
URL: [Attachment_1_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: This attachment highlights essential principles for managing the risks posed by new technologies (including nanotechnology) to health and safety of people and the environment. Chief among them is reviewing the ability of the existing regulatory framework to deliver an efficient and effective response to the new technology while also being mindful that any risk from use of the nano-form of a chemical is no greater than that posed by the conventional form of the chemical or it is at or below the level of acceptable risk. Equally important is a second principle, that in managing risk one should make use of the best scientific evidence available for risk based assessment of the impacts of the new technology on human health and the environment, including the ability to review decisions as new scientific evidence becomes available. Finally, where best available scientific evidence is insufficient to support the safety of the product/chemical, measures to protect public health and safety and the environment can be adopted.
Archived Copy: Attachment_1_PDF_418_7501.pdf



Report Title: Proposal for Regulatory Reform of Industrial; Public Discussion Paper
Report ID: 413
Date: 11/1/2009
Author: National Industrial Chemicals Notification and Assessment Scheme
Report Type: Concept Paper
URL: [NICNAS_Nano_PUBLIC_DISCUSSION_PAPER_PDF.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: This paper provides NICNAS’s stakeholders (the community, industry and government) with the opportunity to comment to NICNAS on a reform initiative to introduce new approaches to the regulation of industrial nanomaterials. The proposal utilizes the existing NICNAS framework, and proposes some adjustments to address uncertainties in potential risks posed by these novel materials to health, safety and the environment. The proposal addresses three elements: regulation of nanoforms of new chemicals, regulation of nanoforms of existing chemicals, and the principle of an integrated approach for industrial nanomaterials within the NICNAS framework as a longer term strategy. As part of this paper, NICNAS is seeking input from stakeholders regarding whether it provides for the sound management of industrial nanomaterials and whether it establishes a clear, regulatory framework for ensuring public health, worker safety, and environmental standards.
Archived Copy: NICNAS_Nano_PUBLIC_DISCUSSION_PAPER_PDF_413_8973.pdf



Report Title: Updated Arrangements for Approved Uv Filters and Assessment of New Uv Filters Used in Cosmetics
Report ID: 165
Date: 10/7/2008
Author: Government of Australia: Department of Ageing and National Industrial Chemical Notification and Assessment Scheme
Report Type: Guidance Document
URL: [2008oct_whole.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: The purpose of this notice is to advise companies of the notification and assessment requirements for UV filters in cosmetic products that fall within the scope of the Industrial Chemicals Notification and Assessment Act 1989. The National Industrial Chemical Notification and Assessment Scheme (NICNAS) had received enquiries regarding the notification requirements for UV filters in cosmetic products. In January 2007 NICNAS published in the Chemical Gazette a notice describing new arrangements for UV filters proposed for use in cosmetic products as well as products covered under the former Cosmetic Interim Arrangement. These legislative changes resulted in the introduction of a Cosmetic Standard which describes the regulatory requirements for six cosmetic product categories with much attention placed on product categories containing sunscreens.



Archived Copy: 2008oct_whole_165_2476.pdf



Report Title: A review of the scientific literature on the safety of nanoparticulate titanium dioxide or zinc oxide in sunscreens
Report ID: 121
Date: 1/16/2006
Report Type: Summary Article
URL: [sunscreen-zotd.pdf]
Country: Australia
Organization: Department of Health and Ageing, Therapeutic Goods Administration (Australian government)
Summary: This Australian government article summarizes existing research regarding the safety of nanoparticle sunscreens containing zinc oxide or titanium dioxide. The use of nanoparticles on the human skin has been identified as potentially dangerous. This document summarizes 24 scientific studies relating to nanoparticles and the skin. It finds some studies linking exposure to zinc oxide and titanium dioxide to free radical production and adverse effects. Other studies involving dermal penetration found that these nanoparticles did not penetrate into lower levels of the skin. Based upon the research summarized, the report concludes that nanoparticles in sunscreens remain on the surface (outer dead layer) of the skin and thus do not pose a health hazard.



 
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