National Industrial Chemicals Notification and Assessment Scheme (NICNAS)

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bulletSee Worksafe for authoritative details.
bulletNICNAS criticism August 1999.

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The Industrial Chemicals (Notification and Assessment) Act 1989 (available as Cat. No. 90 4035 0) established the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) administered by the National Occupational Health and Safety Commission.

NICNAS is aimed at;

bulletcontrolling the introduction of chemicals into Australia; and
bulletthe provision of information into the workplace.

The National Registration Authority for chemicals registered for agricultural and veterinary use (15).

Objective

The objective of NICNAS is to protect people (including in the workplace) and the environment from the harmful effects of industrial chemicals by providing relevant information for application in the workplace and to the relevant State control agencies for action.

Responsibility

bulletImporters and manufacturers who introduce (ie. manufacture or import) chemicals in Australia, must;
bulletcheck the Inventory ; and
bulletobtain an assessment certificate.
bulletUsers, as employers, are required to make summary reports as provided in the Government Gazette, the Chemical Gazette to all employees and their representatives if the substance is used in the workplace.

Introducers of chemicals must notify the Director of NICNAS if new information becomes available on a chemical which indicates increased risk.

Scope of NICNAS

Included

bulletIndustrial chemicals, but see exclusions; and
bulletIngredients of mixtures and formulations which are industrial chemicals.

Although mixtures are excluded from NICNAS, chemicals added to mixtures are subject to NICNAS. It is common practice to improve the performance of a chemical, or a preparation of chemicals, with other chemicals (eg. adjuvants) which are subject to NICNAS. The onus is on the importer/manufacturer to be aware of the formulation and changes to the formulation and to notify the new chemicals.

Excluded from NICNAS

bulletChemicals solely used as the constituents of agricultural chemicals, veterinary drugs, food additives, and human therapeutic substances (which are addressed by other specific regulations);
bulletManufactured articles;
bulletBy-products (ie. incidentally produced chemicals) and reaction intermediates;
bulletSolely for research, development or analytical chemicals and in a quantity not more than 50 kilograms in any 12 month period;
bulletFor commercial evaluation in quantities less than 1 000 kg and up to 1 year (subject to permit);
bulletLow volume chemicals. If of low concern for human health and the environment if introduced in quantities of 100 kg or less annually; and
bulletSynthetic polymers of low concern. Can be notified and assessed.

Existing and new chemicals

Chemicals are either existing or new.

For the purpose of NICNAS, all industrial chemicals are regarded existing or new with different requirements.

Existing chemicals

Chemicals are existing chemicals essentially if included in Australian Inventory of Chemical Substances (the Inventory).

The Inventory is a list of names of chemicals, CAS No.s and molecular formulae.

Currently the Inventory consists of a list of names of about 40 000 chemicals which have been identified as being in use in Australia prior to July 1990.

Unless listed on the Inventory, or exempted, all other industrial chemicals introduced into Australia will be regarded as new chemicals.

The inventory has a confidential section which is not publicly available. Application to the Director of NICNAS is required to establish whether a specific substance is in that section. (See also 14.5)

The Inventory will progressively include other chemicals which have been assessed (whether as new chemicals or priority existing chemicals).

Priority existing chemicals

Existing chemicals may be deemed by a notice in the Chemical Gazette, to become priority existing chemicals (Sections 51 and 52 of the Act). Priority existing chemicals will require an assessment although, unlike new chemicals, importation and manufacturing may continue. Information sought will include;

Properties relating to the health and environmental effects of the chemical as defined in Part C of the Schedule to the Act, and the tests or other ways by which those properties were determined.

Quantities, including as mixtures, imported/manufactured.

Uses or potential uses.

Details of or persons to be supplied.

Methods for handling.

Information (as may be specified) in Part B.

Unless an application is made for an assessment, a priority existing chemical will be withdrawn from the Inventory after 12 months (ie. deemed a new chemical when proposed to be introduced) and may no longer be imported or manufactured.

New chemicals

New chemicals are chemicals which are not listed in the Inventory and are proposed to be introduced into Australia (and not exempted from notification).

Confidentiality

Reference should be made to the NICNAS Handbook for Notifiers and National Policy Statement on the Commercial Confidentiality of Data Relating to Workplace Substances (NOHSC:6004 (1991) AGPS Cat. No. 91 0668 8).

Applicable to all chemicals, assessed chemicals are not included in the Inventory until five years after the issue of the assessment certificate. The Inventory does not include tradenames.

The summary report may not include the chemical name, CAS No and other information which might breach commercial confidentiality.

Commercial confidentiality is recognised where it could reasonably be expected to prejudice substantially the commercial interests of the person making the request.

bulletThe Director of NICNAS may, on discretion, withhold certain information from the public in the publicly available assessment report. The Director will have to determine whether public interest in disclosure outweighs any commercial interest.
bulletInclusion on the Inventory may, on request, be in the publicly unavailable section of the Inventory which is accessible only in writing to the director of NICNAS.

Assessment

Assessment is required for new chemicals and priority existing chemicals. Without an assessment, new chemicals may not be introduced into Australia and priority existing chemicals are withdrawn from the Inventory after 12 months (ie. in future the chemical will be regarded as a new chemical). Assessment details are provided in Section 32 of the Act and the report in Section 33.

An assessment is made on information provided by the applicant. The information is prescribed and standardised for new chemicals and as requested for priority existing chemicals.

Although recognised equivalent overseas schemes may be recognised, for the present given their claimed inadequacy, this provision will have little relevance to most applicants.

The applicant becomes the owner of the assessment certificate. The certificate is prepared within 90 days if a new chemical and 6 months as a priority existing chemical).

The assessment certificate will be provided only to the applicant and confidentially to the relevant State control agencies. A summary assessment report will be included in the Chemical Gazette and a full report is available to the public (except confidential information).

Five years after issuing the assessment certificate, the chemical will appear in the Inventory.

Responsibilities

The responsibilities under the Act (additional to obligations under State and Federal legislation) includes for;

bulletManufacturers, importers and users;
bulletObtain assessment certificates for new chemicals.
bulletComply with notices published in the Chemical Gazette including when an existing chemical is declared a priority existing chemical. If so declared, the chemical may not continue to be introduced without application for assessment.
bulletIntroducers of new chemicals;

Complete an assessment certificate including notification statements, information not specified in the Act and additional information which becomes available during the assessment.

bulletHolders of certificates and subsequent introducers;

Secondary notification requires the holder and subsequent introducers to provide any additional information that becomes available that shows increased adverse health and environment risks to that previously identified to the Director.

Therefore, manufacturers and importers of chemicals, whether for sale or their own use, must know the composition, effects on health and environment and keep up to date with new information.

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