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The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is the Australian government’s regulatory body for industrial chemicals. NICNAS is designed to help protect workers, the public and the environment from the harmful effects of industrial chemicals. It does so by making risk assessment and safety information on chemicals widely available and providing recommendations for safe use.

History

Despite an extensive history of chemical manufacture, use, import and export, it was not until the advancement in manufacturing technologies and processes in the mid 20th century, that the value of chemical assessment and regulation was fully realised. Industrial chemical assessment and regulation is still a relatively new phenomenon for many governments including Australia since they were not subject to governmental review that other types of chemicals (e.g. pesticides and pharmaceuticals) were prior to the establishment of the Acts listed in the below1.

In 1989, the Australian federal government enacted the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act), which led to the establishment NICNAS in 1990. Since then, the Australian government has continued to improve the assessment, regulation and management of industrial chemicals for the protection of human health and safety.

The Rio Earth Summit in 1992 marked Australia’s commitment to the development of Chemwatch1992, marked by the Rio Earth Summit, in 1998 saw Australia's commitment to the development of Chemwatch, the Federal Government has adopted significant changes in chemical assessment regimes and management. They incorporate; the development of a National Profile of Chemical Management Infrastructure and remodelling of chemical assessment regimes under cooperative agreements with New Zealand, Canada and the United States3.

Organisation

Structure of organisation

The structure of NICNAS is a direct reflection of its function. The Director of NICNAS is also the Parliamentary Secretary to the Minister of Health and Ageing. The Director is also a member of numerous committees in order to consult and discuss with relevant industries, key groups and the community to ensure that all are informed and practices comply with standards and regulations set out by NICNAS.

The organisations’ activities flow into three key areas including: business and communication strategy; regulatory strategy; and scientific strategy. Each branch has specific responsibilities that focus on its own area, but retain a certain level of transparency to ensure that all groups work cohesively. Business and communication focuses on office management, finance, corporate governance and media. The regulatory arm concentrates on compliance reporting and reforms. The scientific branch is responsible for notification and assessment, review and treaties, as well as rapid risk assessment.

Another pivotal responsibility of NICNAS is cohesion of Australian legislative measures with international regulations

Scope and funding

All NICNAS activities are funded by the fees charged for the registration of new and existing industrial chemicals as well as the fees and administration charges for the assessment of chemicals. The administration fees and charges are outlined in the cost recovery policy as set out by the Department of Finance and Deregulation.

The recovery cost policy is based on three tier system where the administration charge is fixed for all chemicals being assessed, however, the charge for assessment of a new chemical is based on a formula: 75% Wage Price Index/ 25% Consumer Price Index6.

Legal authority

NICNAS administers the ICNA Act, as well as the Industrial Chemicals (Notification and Assessment) Regulations 1990 and the Cosmetics Standard 2007. The ICNA Act provides a number of enforcement powers to NICNAS (see “Enforcement Powers”).

Functions and powers

NICNAS’ purpose is to help protect workers, the public and the environment from the harmful effects of industrial chemicals. It does so by providing a national system of notification and assessment of industrial chemicals, as well as publicising risk assessment, safety information and recommendations for safe use of industrial chemicals. NICNAS also informs importers and manufacturers of their responsibilities under the Industrial Chemicals (Notification and Assessment) Act 1989 ("the ICNA Act").

Chemical Regulation

The chemical properties and potential health and environmental effects of any new chemical must be notified to and assessed by NICNAS before it is introduced to Australia. Chemicals currently used in Australia are also reviewed and any person may nominate an industrial chemical for assessment. NICNAS then makes this information widely available to the public and industry through its website and publications.

The Australian Inventory of Chemical Substances

The Australian Inventory of Chemical Substances (AICS) is a list of all industrial chemicals used in Australia between 1 January 1977 and 28 February 1990, as well as any additions or corrections to the list since. The AICS is maintained by NICNAS and contains over 38,000 chemicals. Any industrial chemical listed on the AICS is regarded as an ‘existing’ industrial chemical. Any industrial chemical not listed on the AICS is regarded as a ‘new’ industrial chemical.

Risk Assessment and Management

NICNAS conducts two types of risk assessment: quantitative (to measure the risk posed by an existing chemical) and qualitative (to describe the risk posed by a new chemical). NICNAS assessment reports include toxicity, environment, OHS and public health assessments. NICNAS undertakes a four-step risk assessment procedure:

• Hazard identification: determination and description of any adverse effects a substance may cause at any dose
• Hazard characterisation: evaluation of dose-response relationship for each of the adverse effects
• Exposure assessment: evaluation of exposure routes to a chemical in the environment
• Risk characterisation: interpretation and combination of the previous steps to provide a practical estimate of the risk and any limitations and uncertainties.

NICNAS then produces risk management guidelines, which are regularly reviewed. These aim to balance:

• the risk posed by a substance;
• the economic, political and social costs of implementing strategies to minimise or eliminate the identified risk;
• and the social and economic benefits of risk minimisation.

Registration

Any individual or business who wishes to import or manufacture industrial chemicals for commercial purposes must register with NICNAS, regardless of the amount or toxicity of the industrial chemical. Registration lasts for the maximum of one year from 1 September to 31 August in the following year and must be renewed each year. The registration is for the individual or business so that they may lawfully import or manufacture the relevant industrial chemical, not registration of the chemical itself. The Register of Industrial Chemical Introducers lists all of the organisations registered with NICNAS. Registration allows NICNAS to keep people and business fully informed of their legal obligations and safety information. An annual registration fee is charged, which is based on the value of chemicals imported and/or manufactured:

NICNAS Fees and Charges Registration Tier	Value of Industrial Chemicals Introduced	2010-11 Registration Cost
1	≤$499,999	$395
2	$500,000 - $4,999,999	$1,577
3	≥$5,000,000	$9,201

Industrial Chemicals

The definition of an industrial chemical is a ‘catch-all’ phrase designed to cover all chemicals other than identified exceptions. Industrial chemicals include paints, dyes, pigments, solvents, adhesives, plastics, inks and laboratory chemicals. It also includes chemicals used in mineral and petroleum processing, refrigeration, printing, photocopying, household cleaning products, cosmetics and toiletries. Products designed to dispense industrial chemicals (e.g. ballpoint pens dispense ink), articles (e.g. plastic chairs, glow sticks and photographic film) and radioactive chemicals are not included. Other chemicals outside the scope of NICNAS which are regulated by other organisations include:

• Medicines and medicinal products (Therapeutic Goods Administration)
• Pesticides and veterinary chemicals (Australian Pesticides and Veterinary Medicines Authority)
• Food or food additives. (Food Standards Australia New Zealand)

A chemical may have multiple uses. So long as one of those uses is industrial, the person or organisation importing or manufacturing the chemical must be registered with NICNAS. For example, ethylene oxide is used industrially to produce other chemicals and as a fumigant in agricultural products.

Commercial purpose

NICNAS registration is required only when the industrial chemical(s) is to be used for commercial purposes. A commercial purpose includes any use or sale by a business. Non-commercial purposes include personal use, non-profit research, charity, and teaching.

Compliance

NICNAS ensures that importers, manufacturers and exporters of industrial chemicals are aware of and exercise their obligations under the ICNA Act. These include: the registration of industrial chemical importers and manufacturers; chemical-specific obligations associated with new and existing chemicals; and obligations on exporters under international treaties. NICNAS encourages voluntary compliance by industry but also has extensive enforcement powers to ensure compliance.

Enforcement Powers

Informal enforcement powers

NICNAS’ focus on cooperating with industry allows for informal enforcement actions. NICNAS’s enforcement policy states that such actions may be taken where:

• non-compliance was inadvertent and not deliberate;
• it was the first instance of non-compliance;
• the person or business cooperates with NICNAS to with the Act; and/or
• informal action provides adequate deterrence.

Formal enforcement powers

The ICNA Act provides a number of formal enforcement powers to NICNAS:

• the Director may request and gather information as well as revoke permits and certificates;
• Inspectors may monitor compliance, as well as search premises and seize goods relating to an offence against the Act; and
• NICNAS may apply for an injunction to stop an unregistered importer or manufacturer from introducing any industrial chemicals.

A person found in breach of the Act will be liable for fines of up to $33,000 for an individual and $165,000 for a company. Italic text