Welcome

Welcome back to NICNAS newsletter after a short break.

The format of this newsletter has been reviewed and – while this issue follows the “old” format – we are aiming to introduce a revitalised new format early in 2008. At that stage, the content of the two NICNAS publications (this e-newsletter and the hard-copy NICNAS Matters) will be combined and published from then on in a single new, more timely, online publication called NICNAS e-news.

We plan to publish the final edition of NICNAS Matters in February 2008.

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EC Review Implementation Steering Group meets

Advising on roll-out of recommendations

The first meeting of the NICNAS Implementation Steering Group (ISG) was held 1 November 2007. Chaired by Dr Marion Healy, Director NICNAS, the ISG comprises representatives from industry, the community and from government, with Dr Matt Gredley as NICNAS's representative.

Implementation of the recommendations is in accordance with the Implementation Strategy and the Final Report on the Recommendations. The ISG has agreed that the first priority will be the Stream 2 recommendations relating to assessment products, selection criteria and prioritisation processes. A technical workgroup will be formed to assist ISG in this work. The ISG also agreed to a NICNAS consultancy addressing the Stream 3 recommendation on scoping a mechanism for reporting adverse events, the consultancy to focus on data-collection systems already in place.

The Terms of Reference for, and the membership of, the ISG are available on the NICNAS website. Current activities towards implementing the recommendations already being progressed by NICNAS include:

Cosmetics

The Cosmetics Reform Bill passed through both houses of Parliament as a non-controversial bill, receiving Royal Assent on 20 August 2007. It came into effect on 17 September 2007. The new Cosmetics Standard is a legislative instrument which came into effect on the same day. It lists the additional requirements for some cosmetics, including secondary sunscreen products and antibacterial skin products.

Released at the same time – in a revised form – the Cosmetics Guidelines is an administrative document which provides guidance for all cosmetics, including those covered by the Cosmetics Standard. The guidelines include a list of chemicals banned or restricted for use as cosmetic ingredients in Australia.

The interim arrangements which had operated for cosmetics since February 2006 therefore ceased on 17 September 2007. For more information please contact Dr Adrienne Adams.

Disinfectants

A review of disinfectants regulation in Australia is being undertaken in response to the Banks Report, where recommendation 4.61 stated that '...The Australian Government should progress industry reforms for regulating disinfectant products and report progress to COAG.' The review is being undertaken by the Department of Health and Ageing, through NICNAS and the Therapeutic Goods Administration (TGA) and examines the regulatory framework in Australia for hospital grade disinfectants, household/commercial grade disinfectants, antibacterial cleaning wipes, and sanitisers, cleaners and deodorisers. It does not address products defined as sterilants or instrument grade disinfectants.

Currently, therapeutic devices, including disinfectants, must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied. At present:

LRCC

Low Regulatory Concern Chemicals

The final report and recommendations regarding the outstanding LRCC reforms, including implementation of the low hazard and low risk criteria for permits and the modular assessment concept, has been finalised. This will allow the introduction of new categories for low concern chemicals and streamline the notification and assessment process for:

• new chemicals which have been assessed by another regulatory authority in Australia, and
• chemicals which are similar to a chemical previously assessed by NICNAS. 

For more information please contact Mr Bob Graf.

Update on PEC Reports

Fifteen chemicals currently being assessed as PECs

Triclosan - the assessment is a full risk assessment covering occupational, public and environmental risk assessment. A complete review of triclosan has not been conducted either nationally or internationally to date and the Australian report will be the first complete review. NICNAS has sponsored triclosan into the OECD High Production Volume (HPV) Program and following completion of the national final report documents for the OECD Program will be finalised. The NICNAS assessment is now complete and the draft report is being reviewed for final clearance. Triclosan is used in a large number of non-therapeutic cosmetic and personal care products. It is also present in some therapeutic products. Approximately 200 cosmetic and personal care finished end products containing triclosan were imported into Australia in a number of consumer products as an antibacterial agent.  NICNAS expects to release the draft report in the first quarter of 2008.

For information on Sodium cyanide, Polybrominated diphenyl ether and Phthalates ...

Australia recognises Canadian chemicals regulations

Australia has recognised Canadian regulations governing the notification of new industrial chemicals, a step that will help to streamline assessment and approval procedures for these substances in Australia. The move was announced by the then Australian Parliamentary Secretary to the Minister for Health and Ageing, Senator Brett Mason, in a ceremony with the Canadian Minister of Health, Tony Clement, during the Canada-Australia Health Policy Dialogue held in Sydney on 24 August 2007.

Senator Mason and Minister Clement also signed a Statement of Intent to explore collaboration between Australia and Canada on the risk assessment and of existing industrial chemicals.

International Chemical Safety update - New Chemicals

OECD New Chemicals Task Force
Ms Hana Hamdan, Team Leader, Notification and Assessment attended the 11th meeting of the OECD New Chemicals Task Force (NCTF) 12-13 March 2007, Italy and associated meetings held on 10-11 September 2007.

The three major work items under consideration were discussed:

International Chemical Safety update - Existing Chemicals

16th Meeting of the Task Force on Existing Chemicals
Dr Sneha Satya, Team Leader Existing Chemicals attended the 16th Meeting of the Task Force on Existing Chemicals, Helsinki, 19 October 2007 and 25th SIDS Initial Assessment Meeting (SIAM) also in Helsinki.

Since the previous meeting of the Task Force two SIAMs had been held with 35 chemicals discussed at SIAM 24 and over 50 chemicals at SIAM 25. The United Nations Environment Program (UNEP) have published SIDS documents for 57 chemicals on the UNEP website and a further 71 chemical documents have been forwarded by the Secretariat for publication.  Forty IUCLID files have been published on the OECD website.  Each IUCLID contains details of all the available studies for a particular chemical.  In addition to the documents for specific chemicals, the revised guidance for grouping of chemicals has been finalised and is available on the OECD High Production Volume (HPV) website.  The echem Portal was launched in June 2007 with information from five databases.  The NICNAS Priority Existing Chemical (PEC) reports are included in the eChem Portal.  The fifth version of the IUCLID template has also been released.

 For information on the WHO, the OECD HPV program and the 25th SIDS Initial Assessment meetings ...