Key changes since Consultation Paper 1
As a result of stakeholder feedback and further work by NICNAS, this Consultation Paper is proposing some important changes to the way that the reforms are proposed to be implemented. Following is a table summarising the main changes and issues to be addressed. Further detail is included in Parts D to L of this Consultation Paper.
Proposed change in approach
Changes in terminology
Following feedback from stakeholders, NICNAS is proposing to change some of the words and terms used to describe key components of the reforms. For example, stakeholders suggested that referring to the categories of new chemicals as Class 1, Class 2 and Class 3 risks confusing these terms with those used for Dangerous Goods Classification. This consultation paper now describes these categories as Exempted, Reported and Assessed. Further detail is provided in Part D of this paper.
Allow use of international assessment material for self-categorisation against hazard bands
Hazard information requirements for Exposure Band 1
In recognition that the indication of very low risk for chemicals in Exposure Band 1 is driven by the very low exposure (i.e. either research and development ≤100kg, or transhipped chemicals), no hazard characterisation would be needed prior to introduction of these chemicals for the purposes of NICNAS obligations.
Simplifying and refining hazard and exposure bands in the health risk matrix
The hazard and exposure bands of the health matrix have been rationalised and simplified. There were many and varied proposals from stakeholders on ways to improve the matrix, and the revised matrix is the result of considering all of these to come to the most practicable and risk-based framework that achieves the policy objectives agreed by Government. More detailed information is provided in Part E of this paper.
Aligning hazards with the Globally Harmonised System of Classification and Labelling (GHS)
The hazard band criteria for the environment incorporate the GHS classification thresholds. The hazard band criteria for human health have been reviewed to emphasise alignment with GHS classification for each particular hazard endpoint. This means that if the introducer has classified their chemical as corrosive to the skin according to the GHS criteria, then the chemical would be considered corrosive for the purposes of categorising the chemical in the risk matrix. However, NICNAS is proposing to not limit the acceptable hazard information to only that required for GHS classification, so as to allow maximum use of analogues and non-animal test methods and models as they become available.
Assistance for industry in categorising chemicals
It is proposed that NICNAS will provide a categorisation advisory service and make a variety of tools available online to assist industry to categorise their chemicals.
Better definition of ‘environmental release’ and clarification of calculating release volumes
Based on stakeholder feedback and identification of inconsistencies with the current definition, NICNAS is developing a new definition for ‘direct release to the environment’ to ensure that only chemicals with releases to the environment of a significant nature are captured in the definition. More information is provided in Attachment A to this paper.
In illustrating the concept of release volume to determine the environmental exposure band, NICNAS described values of default assumptions for three common uses. While stakeholders were generally supportive of the concept, there were questions regarding the value of 100% anticipated environmental release for cosmetics and domestic products. Currently there is no OECD Emission Scenarios Document to assist industry or regulators in determining an appropriate release percentage for cosmetics and domestic products. NICNAS encourages the presentation of evidence justifying a reduction in the default assumption for 100% environmental release of cosmetics and domestic products.
Addition of ‘contained import/export’ scenario to the health matrix
Following feedback from stakeholders on business practices that do not meet the current transhipment criteria (but which are still low risk) a new scenario has been added to Exposure Band 2 of the health matrix. This is to accommodate the situations in which there is low worker and public exposure to a chemical due to it being imported and stored at the introducer’s warehouse, and then exported without any repackaging or processing.
Reduce assessment timeframe
It is proposed that the assessment timeframe be reduced from 120 calendar days to 90 calendar days. For more detail, refer to Part H of this paper.
Information (data) requirements
Reduce use of animal testing
Information requirements will include greater acceptance of data from similar chemicals (analogues) and non-animal test methods. The expansion of the number of chemicals that do not require pre-market NICNAS assessment due to their relatively low exposure (such as those in Exposure Bands 1 and 2 of the health risk matrix) means fewer chemicals will require information to be available on all hazard endpoints. Thus, there will be even greater flexibility in the information used to determine any risks of introducing the chemical. Waivers to information requirements will also offer an avenue for reducing toxicological testing (especially of animal testing). For more detail on data requirements, refer to Attachment B of this paper.
Polymers of low concern (PLCs)
More appropriate treatment of PLCs
Based on feedback on Consultation Paper 1, NICNAS has modified the original proposal relating to the treatment of new PLCs. Specifically, it is now proposed that most new polymers meeting the PLC criteria be categorised as Exempted chemicals. This means that the regulatory burden would be less than that imposed on introducers in the United States of America (USA) in respect of the same polymer. Introducers of new polymers eligible for polymer exemption in the USA (equivalent to PLCs in Australia) are required to submit annual reports on the number of exempted polymers for which their introduction commenced during the preceding year. In contrast, under the NICNAS reforms, PLCs would have no annual reporting requirements.
Class 2 (Reported chemicals)
Simplified annual declaration
Stakeholders expressed concern that a requirement for annually declaring Reported (formerly Class 2) chemicals would be cumbersome. NICNAS proposes to introduce a simple, automated online declaration system that will simply record a declaration that the chemical continues to meet the criteria for Reported chemicals (no additional information required regarding volume, use, etc.).
Australian Inventory of Chemical Substances (AICS)
Pathways to AICS for Exempted and Reported chemicals (previously Class 1 and 2 chemicals)
The only pathway to AICS under the reforms would be following a NICNAS assessment.
As proposed in Consultation Paper 1, an introducer of a chemical that falls within the categories of Exempted and Reported may choose to apply for an assessment of the chemical by NICNAS. This will provide a pathway to AICS for such chemicals.
CAS registry number (RN)
A single substance can sometimes have multiple CAS descriptors. When only one of the CAS RNs for such a chemical is on the AICS, there can be uncertainty as to whether the chemical can be introduced into Australia as an existing chemical under the other CAS RN. NICNAS proposes to introduce a new mechanism for adding CAS RNs to AICS (see discussion in Part J).
Length of transition period for new chemicals under exemptions, permits or certificates at the commencement of the reforms.
In Consultation Paper 1, NICNAS proposed a transition period of 6 months. A number of stakeholders commented that this period was too short or that decisions about a transition period could not be made at this early stage in the development of the reforms. NICNAS therefore proposes deferring the decision on the length of the transition periods until later in the consultation period, but can confirm that the proposed period would be greater than 6 months.
Last update 17 February 2016