Use of international information and assessments
Acceptance of approvals and bans
Why won’t NICNAS automatically accept approvals and bans from other regulators?
Approvals and bans made by other regulators or risk managers are regulatory decisions made in specific jurisdictional, geographical and legal contexts that are not fully aligned with one another internationally, and similarly not fully aligned with the Australian context.
International ‘approvals’ take different forms, and are based on different national/regional risk management frameworks. These differing frameworks mean that an assessment underpinning an ‘approval’ (or other regulatory decision) may leave out aspects that NICNAS must consider, or include aspects beyond NICNAS’s mandate.
International ‘bans’ are similarly made in specific contexts: for example, some bans are made on a precautionary basis, before thorough examination of safety data. Australia does not have a history of precautionary ‘bans’ that may ultimately be found to have been unwarranted.
The NICNAS reforms are founded on the principle of risk-based proportionality. This requires NICNAS to most closely examine those chemicals of greatest risk to human health and the environment, and create processes to de-prioritise those of lesser risk. To do this, NICNAS will use international data to the extent possible. This includes using certain international assessment outcomes as a streamlined pathway towards de-prioritisation of new chemicals so that pre-market assessment is no longer required. It does not, however, extend to automatic adoption of regulatory decisions beyond those specifically identified for particular regulatory pathways. Rather, the NICNAS reforms aim to build a framework for managing the diversity of international approaches, including where there may be conflicts in decisions made by different international jurisdictions. NICNAS will continue to participate actively in international fora (such as OECD) to achieve increased international harmonisation of regulatory approaches.
In Australia, why are the ingredients of cosmetic products regulated as industrial chemicals?
Cosmetic products and their ingredients are regulated in a range of different ways in other countries. Some countries have established specific schemes for cosmetics, while other countries regulate them under regimes established for industrial chemicals, or under food and drug legislation.
The Australian Government regulates chemicals according to their use. Since industrial uses are defined by exclusion (i.e. industrial chemicals are those that are not regulated as chemicals used in food, therapeutic goods, or agricultural or veterinary products), cosmetic ingredients default to regulation by NICNAS.
In 2007, in response to industry concerns, some types of cosmetics previously regulated as therapeutic goods in Australia were declared to be excluded from regulation by the Thereapeutic Goods Administration (TGA), and therefore the chemical ingredients of these products became regulated by NICNAS. This resulted in a significant reduction in regulatory burden for the cosmetics industry.
The NICNAS reforms do not contemplate a change to these arrangements; in fact, by adopting a more risk-based and proportionate approach, the reforms specifically recognise the types of exposure associated with cosmetic uses of chemicals and do not treat cosmetic ingredients in the same way as chemicals with other industrial uses.
Under the reforms, chemicals used in cosmetics that are not hazardous, and chemicals introduced in low concentrations in formulated products, are subject to a ‘light touch’ regulatory approach. Only a very small proportion of new cosmetic ingredients (those with both higher hazard and higher human and/or environmental exposure) are likely to be subject to assessment by NICNAS following the reforms, significantly fewer than under current arrangements.
If a cosmetic product is able to be marketed in another country, will it automatically be able to be marketed in Australia?
The only cosmetic products that would not have ‘automatic’ market entry under the NICNAS reforms are those that contain chemicals that are not already listed on the Australian Inventory of Chemical Substances (AICS),and are of sufficient hazard and exposure (for human health and/or the environment) to warrant assessment by NICNAS.
The NICNAS reforms propose a pathway to market without assessment by NICNAS for cosmetic products whose ingredients have been subject to a comparable level of health and environmental assessment as would be required in Australia (i.e. meet the criteria approved by the Minister for Health for acceptance of international standards and risk assessment materials) and provided that any risk mitigations required by the international regulator are in place in Australia.
Will the NICNAS reforms create barriers to trade? Specifically, are the reforms consistent with the terms of the WTO Agreement on Technical Barriers to Trade (TBT) and related parts of the Trans-Pacific Partnership Agreement (TPP)?
Like the existing regulatory framework, the NICNAS reforms would conform to TBT requirements and would not give domestically produced goods any unfair advantage over imported goods. Regulatory requirements will be identical for chemicals imported into, and manufactured in, Australia. The NICNAS reforms are:
- consistent with the TPP; namely, conform with its encouragement of pursuing international collaboration in the development of harmonised technical standards, and seeking to take a risk-based approach to regulation, and
- within the express exception provisions in both the TBT and TPP, being measures to protect human health and the environment, that are not prepared, adopted or applied with a view to, or the effect of, creating unnecessary obstacles to international trade. However, regardless of this, the reforms are being developed with the express aim of conforming to the growing trend, articulated in the TBT and TPP, for international harmonisation of ‘technical standards’, for example by aligning the risk matrices with GHS hazard classification.
As is the case with any reform of this type, the Australian Government intends to notify the WTO Committee on Technical Barriers to Trade about the NICNAS reforms, when the detail of the proposed reforms has been sufficiently developed.
International alignment—standards and information
What are some of the specific ways that the reforms will align internationally?
Internationally, regulatory frameworks and approaches to assessing and managing risks arising from chemicals are not aligned. Different international jurisdictions—countries and regions—have different frameworks and approaches to each other, based on differences in legal, organisational, population, environmental and industry contexts. It is thus not realistic to discuss a single notion of NICNAS becoming ‘aligned’ with such diversity. Additionally, the NICNAS reforms are founded on risk-based proportionality, which is not necessarily the foundation of other international regulatory regimes.
Nevertheless, NICNAS reforms seek to make the best use of international data, materials and outcomes, and align with specific elements of international jurisdictions, frameworks and processes to best achieve a risk-based proportionate outcome. This includes the establishment of processes and pathways for identifying lower-risk chemicals and scenarios and removing them from detailed examination (an approach not yet widely adopted internationally).
The NICNAS reforms are designed to reduce any unnecessary or disproportionate regulatory impost by aligning internationally, for example by establishing a pathway for downgrading a chemical into the Reported chemical category where an international risk assessment outcome has been reached by a trusted foreign regulator and that outcome is relevant in the Australian context. In addition, the information requirements for human health in Exposure Bands 3 and 4 have been set so that they align as closely as possible with the requirements for the same type of chemicals introduced into the EU and Canada.
In other aspects, the NICNAS reforms do not align with international approaches because to do so would be contrary to the overarching policy imperative for risk-based proportionality in the application of regulatory effort. For example, the NICNAS reforms propose to adopt the international trend towards moving beyond simple volume surrogates for exposure (thereby identifying lower risk scenarios that can be removed from more detailed interrogation). While considered best practice internationally, this approach has been developed to a sophisticated level, but is not yet widely implemented for regulatory purposes. For example, there is ongoing OECD activity to develop online tools that quantify the extent of release of a chemical, specific to particular environmental compartments (for example, surface water), based on the use. This would differentiate between, for example, a fertiliser additive that is expected to run-off directly to surface water, and a monomer that is almost entirely consumed in polymer production. Without such an approach, the worst-case assumption of 100% release would be made in both cases, with inappropriately equal regulatory attention paid to evaluating the ecotoxicity risks of each chemical.
Why don’t the exposure band volumes align with comparable international schemes?
The information requirements for human health (as described in this paper) more closely align with comparable international schemes (although noting that not all the comparable international schemes are aligned with each other). In particular, the introduction volumes for Exposure Band 3 (1–10 T) and Exposure Band 4 (>10 T) for non-cosmetic use, and the associated information requirements, have been more closely aligned with the requirements for these chemicals in Canada and EU (for example, evaluation of repeated dose toxicity is only an information requirement for these chemicals above an introduction volume of 10 T).
For chemicals used in cosmetics, the volume thresholds have not been aligned with EU REACH volume thresholds as REACH does not consider the public health risks arising from use of cosmetic ingredients. In the EU, the management of these risks is governed by the Cosmetics Regulations, which includes requirements for safety assessments of each new product to be conducted by industry. There is no lower volume threshold for when these cosmetic safety requirements apply. The required product safety assessment is based on the ingredients within that product, and so any new ingredient within a product will need to have information to inform the safety assessment of the product. This information should therefore be available for the categorisation of new cosmetic ingredients being introduced into Australia.
Exposure of both the public and the environment is dependent on two critical factors that differ widely between Australia and some international jurisdictions; namely, population size and environmental conditions.
Australia’s specific variables, such as, the small size of Australia’s population, and the aridity of large parts of its environment, mean that exposure calculations and banding cannot be adopted wholesale from international schemes.
Additionally, in order to become more proportionate and risk-based, NICNAS is adopting the international trend to move away from volume as a simple surrogate for exposure. For example, environmental release volume is a key aspect of the environmental risk matrix, whereby it is possible to establish lower exposure than would be the case if the more common international assumption of 100% release of introduced volume were made.
Why is the US EPA not considered a trusted source for the purpose of accepting international assessment materials as a pathway to introduction as a Reported chemical that would otherwise be categorised as requiring NICNAS assessment?
The proposed pathway for Assessed chemicals to be introduced as Reported chemicals, based on a risk assessment by an international regulator, requires the application of criteria approved by the Australian Minister for Health. Initial consideration by NICNAS of the US EPA against these criteria (set out in Consultation Paper 1) did not result in NICNAS proposing the automatic adoption of regulatory decisions by the US EPA due to issues relating to transparency (US EPA does not publish its assessment reports) and differences in regulatory coverage (the US EPA does not assess the public health risks from use of cosmetics; in the USA this is done as an industry self-assessment of product safety).
In responding to this second Consultation Paper, stakeholders are invited to submit how these criteria could be met by other international regulators (such as the US EPA) through information being made available in addition to those articulated in Consultation Paper 1.
It is anticipated that the ‘trusted sources’ for this pathway will not be prescribed in primary legislation, but in legislative instrument/s developed at a later time after further stakeholder consultation.
Why can’t NICNAS use the information provided by other recognised international scientific authorities? Why aren’t we relying on a wider range of organisations, for example, OECD, SCCS, CIR, Chinese Ministry of Environmental Protection?
While it will be possible, under the reforms, to use information provided by a range of international scientific organisations to support categorisation of a chemical, or to satisfy data requirements for a NICNAS pre-market assessment, the acceptance of international material as a basis for downgrading an Assessed chemical into the Reported chemical category is necessarily more limited because of the higher risk associated with the use of such chemicals. This process is governed by the criteria established by the Minister for Health for the adoption of international standards and risk assessment materials by the Health portfolio regulators, which are designed to ensure transparency and rigour when Australia accepts an overseas assessment of a higher risk product (or chemical in this case) without undertaking its own assessment.
Crucially, the international material must constitute a risk assessment, with a corresponding regulatory decision, made by a comparable regulator. Assessments conducted under the OECD Parallel Process are likely to be acceptable for the purposes of downgrading an Assessed chemical into the Reported chemical category, as these assessments are conducted by comparable regulators, with the involvement of NICNAS. However, a number of international organisations identified by stakeholders are not suitable because they are not regulators or do not publish a risk assessment.
For the purposes of downgrading the Australian regulatory oversight of a chemical from Assessed to Reported (based on an international assessment by an international regulator) the following international organisations (identified by stakeholders) are not suitable because they are not regulators or do not publish a risk assessment. For example:
As described in Consultation Paper 1, SCCS outcomes that have been adopted by the European Commission are currently proposed to be accepted as the basis of a chemical that would otherwise be assessed by NICNAS to be categorised as a Reported chemical for human health risks. For example, a new hair dye ingredient that has been assessed by SCCS and added to Annex IV of the EU Cosmetics Regulation would not need re-assessment by NICNAS for its human health risks prior to introduction and so could be categorised as a Reported chemical for human health. As the SCCS does not assess the environmental risks, categorisation of the hair dye according to the environmental matrix would still be required, which could result in the chemical being either a Reported or Assessed chemical overall.
Last update 17 February 2016