TGA News Issue 40 (March 2003) - Chemicals
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Australian high volume chemicals list
NICNAS, in cooperation with industry, has compiled the Australian High Volume Industrial Chemicals List (AHVICL) - a list of industrial chemicals that are manufactured in and imported into Australia in large quantities. High volume chemicals are those imported and/or manufactured in volumes greater than or equal to 1000 tonnes/year.
The compilation of the AHVICL occurred in two stages and for each stage information was sought from over 640 companies registered with NICNAS. During 2000, information was sought on individual chemicals manufactured in Australia during the 1999 calendar year. In 2001, similar information was sought on chemicals imported into Australia for any 12-month period between 1999 and 2001. Overall some 300 chemicals are on the list.
For each of the high volume chemicals, the AHVICL contains the chemical name and CAS number and use information in the form of 'Industry' and 'Use' categories assigned by companies.
Analysis of the list provided some interesting information.
- Twice as many chemicals are imported into Australia than manufactured locally. However, four times the total volume of high volume chemicals are manufactured locally, compared with imported.
- More than twice as many companies import high volume chemicals than manufacture locally. Around one-fifth of all companies indicate activity in both importation and manufacture.
- The most nominated identifiable Industry category was "Chemical Industry: Chemicals Used in Synthesis" followed by "Paints, Lacquers and Varnishes". The most nominated identifiable Use category was "Cleaning/Washing Agents and Additives", followed by "Solvents".
The AHVICL is on the NICNAS website <http://www.nicnas.gov.au>.
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Endocrine disrupting chemicals
Global concerns have been raised in recent years over the potential harmful effects of exposure to chemicals that have the potential to interfere with the endocrine system (EDCs). This concern is directed at both humans and wildlife. The potential harmful effects of EDCs and the implications for human health remain the subject of ongoing scientific investigation, with worldwide collaborative research and development of screening and testing strategies to detect endocrine disrupting effects.
An updated position paper on EDCs has recently been published on the NICNAS website <http://www.nicnas.gov.au/foreign/endocrine.asp>. This paper, coordinated by NICNAS, was prepared in cooperation with the Commonwealth Government agencies: the Therapeutic Goods Administration, Environment Australia, Food Standards Australia New Zealand and the National Occupation Health and Safety Commission.
The paper provides a description of EDCs and the background to the ongoing concern over the issue, as well as an outline of the main international activities, an overview of Australia's regulatory position and links to relevant websites.
Member countries of the Organisation for Economic Cooperation and Development (OECD), including Australia, are developing a harmonised testing strategy for EDCs. The United States Environmental Protection Agency developed a screening program that is currently in an implementation stage. Standardisation and validation of some of the tests are underway.
Global cooperation - Canada
Australia and Canada signed the Australia-Canada Bilateral Arrangement in May 2002 and August 2002, respectively.
The objective of the Arrangement, which covers new chemicals regulation, is to obtain meaningful financial and other benefits for governments and notifying companies in both countries. The scope of the Arrangement includes expanding knowledge and information exchange (including confidential information exchange), scientific and regulatory consultancy services, work sharing on co-notifications, advancing scientific tools, short-term staff exchange and special projects.
The long-term goal is to be able to approve the Canadian scheme as an Approved Foreign Scheme for the purposes of the Industrial Chemicals (Notification and Assessment) Act 1989.
Global cooperation - New Zealand
In November 2002, NICNAS and Environmental Risk Management Authority (ERMA) New Zealand were signatories to a Memorandum of Understanding (MOU), which established a cooperative relationship between the two agencies in relation to industrial chemicals that may also be hazardous substances.
The aim of the MOU is to actively maintain this cooperative relationship in order to enhance the efficient and effective administration of complementary aspects of each party's regulatory processes, including access to and exchange of information (subject to statutory provisions as they apply to each agency) and expertise.
Both parties are committed to working together to promote international harmonisation of chemical safety assessments through activities under the OECD New and Existing Chemicals Programmes, the International Programme on Chemical Safety (IPCS), Chemicals Management Programme and the Globally Harmonized System for Classification and Labelling of Chemicals.
Low regulatory concern chemicals
The Parliamentary Secretary for Health and Ageing, the Hon Trish Worth MP, and the Federal Minister for Industry, Tourism and Resources, the Hon Ian Macfarlane MP, met with the Chemicals and Plastics Leadership Group on 19 February 2003. Ms Worth has a lead role in implementing the Government response to the Chemicals and Plastics Action Agenda by coordinating the regulatory reform agenda.
The Action Agenda addresses four issues vital to the chemicals and plastics industry's future prosperity:
- regulation reform
- investment in growth
- an innovative culture
- a highly skilled workforce.
For further information see the Department of Industry, Tourism and Resources website <http://www.industry.gov.au>.
The Action Agenda provides a valuable framework to pursue reform of industrial chemicals regulation, and in particular to pursue reform of low regulatory concern chemicals (LRCC). The Government has agreed to consider options to fast track assessment processes to enable industry to access adequately assessed and/or tested chemicals more quickly. The aim of the reforms is to introduce flexibility into the industrial chemicals assessment process and to reduce the regulatory burden on industry and small business without compromising public health or the environment. Ms Worth has agreed to provide a report on progress with the regulatory initiatives to Minister Macfarlane by 30 June 2003. The LRCC reform initiative will be complete with the issue of a report containing recommendations to improve the efficiency of industrial chemicals regulation in Australia.
The National Industrial Chemicals Notification Assessment Scheme (NICNAS), the Government's industrial chemicals regulator, has been given the task of implementing reform of the LRCC category.
In implementing the Government responses to the Action Agenda, both Government and industry have agreed that the following four principles apply.
- No grandfathering of unassessed chemicals from Europe or elsewhere, as such chemicals could pose a health and environmental risk to all Australians.
- Cost-recovery is accepted Government policy and is not open for renegotiation.
- The new measures recognise the importance of regulation to protect public health and the environment but are aimed at reducing the compliance burden on the industry.
- Industry recognises the need for a national approach to ecologically sustainable chemicals management and regulation.
What are low regulatory concern chemicals?
Due to the diverse nature of what constitutes "low regulatory concern", there is difficulty in defining a single category or set of guidelines which readily capture the scope of possible reforms. The approach to date has been to identify case-by-case scenarios, which are then used to define or constitute a set of categories under the umbrella of "low regulatory concern".
Given the significant policy implications of introducing a lower level of assessment requirement/standards, considerable public consultation will be required. It will be important to ensure that the community and downstream chemical regulators are assured of safety and environmental standards. A background paper on the LRCC initiative is available on the NICNAS website <http://www.nicnas.gov.au>.


