Diana M. Bowman

Nanomaterials and regulation of cosmetics

To the Editor — In November 2009 the member states of the European Union (EU) agreed to recast some 55 directives relating to cosmetics into a single regulation on cosmetic products1 that is intended, among other things, to streamline human safety requirements and increase transparency. The adoption of this regulation is significant, not least because it is the first piece of national or supranational legislation to incorporate rules relating specifically to the use of nanomaterials in any products. Nanomaterials have been widely adopted by the cosmetics industry2,3 as a way of adding value to existing products and new products4. As such, the inclusion of the nanospecific provisions will apply to many products within the cosmetics industry. Environmental safety considerations will continue to be covered by the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation that came into force in June 2007. Cosmetics are defined to include, for example, creams, make-up products, toothpaste and sunscreens1. The initiative is also significant as it is inconsistent with the EU’s statement in 2008 “that current legislation covers to a large extent risks in relation to nanomaterials and that risks can be dealt with under the current legislative framework.”5 Under the regulation on cosmetics, anyone placing a new cosmetic product containing nanomaterials onto the EU market will be required to supply the European Commission with safety information six months before its planned entry onto the market. Manufacturers of nanoscale cosmetic products that are already on the market will be required similarly to notify and submit safety data to the Commission (ref. 1; article 16(3)). Should the European Commission have concerns about the safety of the nanomaterial in use, it is required to seek the opinion of the Scientific Committee for Consumer Safety, and any such opinion must be made publicly available (ref. 1; article 16(4)). The regulation also requires the European Commission to create a publicly available catalogue of “all nanomaterials used in cosmetic products placed on the market ... and the reasonably foreseeable exposure conditions” (ref. 1; article 16(10)(a)). The lack of transparency about the presence of nanomaterials in consumer products was clearly a concern in the run-up to the regulation. Products containing nanomaterials — which are defined as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm” (ref. 1; article 2(k)) — must indicate the presence of the nanomaterial(s) in the list of ingredients. This will be done by placing the word “nano” in brackets after the nanoscale ingredient (ref. 1; article 19(1)(g)). Importantly, the regulation does not set a minimum threshold for this labelling requirement, which suggests that the mere presence of any nanoparticles in the cosmetic will be enough to trigger this requirement. The inclusion of nanospecific provisions evidently creates a further layer of legal obligations for companies wishing to gain a competitive edge through the inclusion of nanomaterials in their products. Unless the benefits of using nanomaterials outweigh these costs, it is possible that some companies may reformulate existing nanobased products so that the particles fall outside — even slightly — the size range specified in the regulation. In that respect, the definition of “nanomaterials” as referred to above may miss its target. Different jurisdictions already take different approaches to the regulation of nanomaterials, and the introduction of nanospecific regulations in the EU has the potential to amplify these differences. However, with the EU now starting to regulate nanomaterials, other jurisdictions might also be encouraged to ‘ratchet up’ their own regulatory frameworks in the short-to-medium term. ❐

Nanotechnology and Public Interest Dialogue: Some International Observations

This article examines nanotechnology within the context of the public interest. It notes that though nanotechnology research and development investment totalled US

‘Governing’ nanotechnology without government?

9.6 billion in 2005, the public presently understands neither the implications nor how it might be best governed. The article maps a range of nanotechnology dialogue activities under way within the United Kingdom, the United States, Germany, and Australia. It explores the various approaches to articulating public interest matters and notes a shift in the way in which these governments, on the whole, appear to be attempting to manage nanotechnology “risks.” It argues that open and transparent policy deliberations and extensive public discourse will be pivotal to protecting the public interest, gaining public trust and acceptance of nanotechnologies. The article concludes that though governing emerging technologies in the public interest is not a new concept, nanotechnology does present additional challenges that must be addressed by the guardians of the public interest.

The problem of regulating sophisticated materials

The increasing commercialisation of products containing nanomaterials has been accompanied by growing societal concerns. These concerns have underpinned a debate over the degree to which governments should specifically ‘govern’ or regulate nanotechnology. This paper examines the way in which the private sector is developing innovative regulatory arrangements for nanotechnology. It commences with a theoretical review of potential regulatory tools, and then discusses how two multinational companies are developing their own regulatory mechanisms to guide the responsible development of nanotechnology. It concludes that whilst governments will no doubt play a crucial role in the regulation of the technology, nano-specific state-based regulation will probably only constitute part of an evolving regulatory web. Copyright , Beech Tree Publishing.

Factors associated with return-to-work and health outcomes among survivors of road crashes in Victoria.

As complex new materials such as nanoparticles increasingly make their way into commercial products, regulatory frameworks need to overcome a number of key challenges to remain fit for purpose.

Does REACH go too far

Objective: To explore the relationships between injury, disability, work role and return‐to‐work outcomes following admission to hospital as a consequence of injury sustained in a road crash.

A review of critical factors for assessing the dermal absorption of metal oxide nanoparticles from sunscreens applied to humans, and a research strategy to address current deficiencies

Uncertainties in new regulations that cover the manufacture, importation and production of chemicals in the European Union could make it more difficult to commercialize nanotechnology.

Hitting the mark or falling short with nanotechnology regulation

Metal oxide nanoparticles in sunscreens provide broad-spectrum ultraviolet protection to skin. All studies to assess dermal penetration of nanoparticles have unanimously concluded that the overwhelming majority of nanoparticles remain on the outer surface of the skin. However, possibly due to many different experimental protocols in use, conclusions over the potential penetration to viable skin are mixed. Here, we review several factors that may influence experimental results for dermal penetration including the species studied (human, or animal model), size and coating of the metal oxide nanoparticles, composition of the sunscreen formulation, site of sunscreen application, dose and number of applications, duration of the study, types of biological samples analysed, methods for analysing samples, exposure to UV and skin flexing. Based on this information, we suggest an appropriate research agenda involving international collaboration that maximises the potential for dermal absorption of nanoparticles, and their detection, under normal conditions of sunscreen use by humans. If results from this research agenda indicate no absorption is observed, then concerns over adverse health effects from the dermal absorption of nanoparticles in sunscreens may be allayed.

Public awareness of corruption in Australia

Regulation of all new technology ebbs and flows between periods of under- and over-regulation, often dependant on the viewpoint of the observer and the underlying objectives of the particular regulation. As illustrated by genetic modification (GM) applications, defining what constitutes appropriate regulation for a rapidly evolving technology can be difficult. Drawing upon the lessons of GM, we argue that nanotechnology will go through similar periods of inappropriate regulation. As with GM, future regulatory responses to nanotechnology will be shaped by perceptions of risk and willingness to accept varying levels of risk. With varying responses between jurisdictions appearing inevitable, we argue that the timing and type of regulation adopted for nanotechnology, and its appropriateness, will be crucial to its commercial success.

Reviewing the regulatory barriers for nanomedicine: global questions and challenges

Purpose – The aim of this paper is to examine public awareness and perceptions on corruption in Australia, a country that traditionally has been viewed as having relatively low levels of corruption.Design/methodology/approach – The paper presents the findings of a random telephone survey of 300 people aged 16 and above, across the three most populated Australian states.Findings – The paper suggests that corruption may be a greater issue of concern for the Australian public than has been assumed in the past, given the relatively low levels of reported systematic corruption in Australia. Moreover, while there may be widespread agreement that corruption in Australia is harmful and perhaps inevitable, people can find it difficult at times to differentiate between what is corrupt and what is not.Originality/value – The findings presented in this paper illustrate that corruption is an issue of concern for members of the Australian public, with the majority of respondents agreeing that corruption seems to be inc...