About priority existing chemicals
Last update 30 November 2016
What is a priority existing chemical?
A Priority Existing Chemical (PEC) is an industrial chemical which has been declared by the Health Minister for NICNAS to assess in detail because there are reasonable grounds to believe it gives rise, or may give rise to, adverse effects on worker health and safety, public health and/or environment—either through manufacturing, handling, storing, using or disposing it.
A chemical can be declared as a PEC following a recommendation from the Director of NICNAS to the Health Minister. Prior to recommendation NICNAS publishes a notice in the Chemical Gazette to obtain information about a particular chemical or group of chemicals from anyone who may hold information. A PEC can be assessed as a single chemical or a group of chemicals to increase efficiencies in the assessment process.
Once a PEC assessment has been published, the chemical is no longer a PEC.
Following a chemical assessment by NICNAS, there could be changes in circumstances that would later require particular aspects of a chemical to be re-assessed. This process is called secondary notification and assessment.
Publication of the assessments supports informed and scientifically-based regulatory action to be undertaken by Commonwealth, state and territory regulatory bodies.
The PEC assessment process was reviewed as part of an overall evaluation of the Existing Chemicals Program in 2007–2008. Download Uptake of NICNAS’s Priority Existing Chemical Recommendations by Government Chemical Management Bodies [PDF 56 KB].
Selection of a priority existing chemical
Nominations to declare a PEC may come from a company, union, industry body, individual, government department or non-government organisation. NICNAS may nominate a chemical listed on the AICS for assessment as a PEC at any time.
NICNAS has called for nominations of chemicals as potential PECs from the public and wider community in the past. The nominated chemicals were screened against set criteria including volume of use, potential exposure and severity of occupational health and safety, public health and environmental effects.
Following consultation with other government departments, industry, unions and the public, NICNAS drew up a candidate list of chemicals to consider declaring as PECs.
Declaring and assessing priority existing chemicals
If you are importing or manufacturing chemicals declared as PECs, you must apply, under the Industrial Chemicals (Notification and Assessment) Act 1989 for NICNAS to assess the chemicals. If no application is lodged after a chemical is declared a PEC, the NICNAS Director can request the assessment report to commence.
The Director may require relevant persons to supply detailed information on the importation and manufacture of a chemical and on worker health and safety, public health and environmental effects for the PEC assessment. Supplying such information is compulsory.
NICNAS depends on information provided directly by importers or manufacturers of the chemical in Australia (as a result of calls for information), overseas organisations and in the published literature to assess chemicals. Wherever possible, NICNAS refers to international chemical reviews and reports, to improve efficiency and minimise duplication.
The overall assessment involves consultation with PEC applicants, other suppliers of information, regulatory agencies and other interested or relevant persons. Opportunities are provided for people to comment on draft reports. Decisions on any requested variations to the final assessment reports are made by the Director. A person may appeal these decisions through the Australian Administrative Appeals Tribunal.
When providing information for a PEC assessment, you can submit an application claiming that certain content should be treated as confidential, as long as you justify your request. If the application is approved by the Director the information will be 'exempt' from publication. To make an application you need to complete Form 3, detailing what you need to be kept confidential. At the same time, you should send your nominated fee payment.
Assessment report contents
A PEC assessment report reviews the weight of evidence relating to human health and environment exposure, hazards and risks associated with the use of the chemical. It determines the quality of each piece of scientific evidence in terms of its reliability, relevance and fitness for purpose. Scientific methods are identified for assessing risk; the uncertainties in a risk assessment are explained and risk management recommendations are made to industry, regulatory agencies and the public.
While the contents of all PEC assessment reports differ—depending on scope and matters that need to be taken into account—most contain important information on:
- chemical identity, physical and chemical properties
- manufacture, importation and use
- health and environmental exposure and hazards
- human health and environmental risk characterisation
- current health and environmental risk management
- recommendations for risk management
- post-assessment reporting obligations for secondary notifications.
PEC assessment reports do not contain exempt information.
Regulatory controls may include hazard classification, exposure standards, health surveillance and other matters such as substitution, ventilation, safe work practices and emission control systems.
Post-assessment reporting obligations
The Secondary Notification of a chemical previously assessed as a PEC may be required where NICNAS or a person introducing, or has introduced, the chemical becomes aware of circumstances that may warrant reassessing its exposure hazards and risks.
The NICNAS assessment report lays out circumstances under which you must advise the NICNAS Director of post-assessment obligations. It is the importer's or manufacturer's responsibility to inform the NICNAS Director of a change of circumstances and this must be done within 28 days of the changed circumstance. Obligations are detailed under Section 64, Division 6, of the Act.
Removing a chemical from AICS
The NICNAS Director must remove a chemical declared a PEC from the AICS when:
- no application for its assessment as a PEC has been received within 12 months after declaration
- the chemical has not been assessed under the NICNAS Director's instruction.