Geert Van Calster

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. ❐

Does REACH go too far

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.

Taking Temperature - A Review of European Union Regulation in Nanomedicine

Nanomedicine, the application of nanotechnology to healthcare offers numerous improvements to medical diagnosis, drug delivery, therapy and implants. The potential impact of nanomedicine is foreseen radically to change health care; however it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance. This paper introduces the emerging field of nanomedicine and then proceeds to detail the current regulatory framework and regulatory bodies in the European Union relating to medicinal products, medical devices, biologics and therapies. This is followed by a detailed analysis of two nanomedical applications in the context of regulatory challenges. The paper concludes with a discussion of the adequacy of the current regulatory regime in Europe and where problems are likely to arise as nanomedicine evolves.

A Nanotechnology Legal Framework

Publisher Summary This chapter discusses the nanotechnology level framework. Legal issues intersecting with nanotechnology research, development, and commercialization include intellectual property; workplace and occupational liability; commercial/contractual liability; environmental regulation; food and drug regulation; consumer product safety; tort and product liability; and end-of-life disposal issues. For conceptual purposes, the legal life cycle of a nanotechnology product has five distinct stages: supply, manufacturing, intermediate use, consumer, and end-of-life disposal. The first stage in the conceptual nanotechnology product legal life cycle is the “supply stage.” A supplier is a company that does not make a final nanotechnology- based product, but rather creates a precursor which it then sells to others. The second stage in the nanotechnology product legal life cycled manufacturing–most often comes to mind when someone explains that their company is making a new nanotechnology product–some type of end product that can be held and/or seen. The third stage in the nanotechnology product legal life cycle–intermediate use–occurs when a business takes a completed product of another company and then incorporates it into its own product. The fourth stage in our nanotechnology legal product life cycle is the “consumer” stage. This stage is reached when an ultimate product is sold into the hands of “Joe and Jane Public” who then use the product for its intended purpose. The fifth and last stage of the conceptual nanotechnology legal product life cycle is the “disposal” stage. “Joe and Jane Public” are done using the product after its intended useful life and then get rid of it–usually by throwing it in the trash where it ultimately ends up in a landfill or less often in an unregulated dump.

Defining Nanomaterials for the Purpose of Regulation within the European Union

Consumer desire for superior and/or new products has provided industry with the opportunity and market demand to incorporate and experiment with new technologies, including nanotechnologies. While these products and processes have fallen under the scope of existing regulatory frameworks, potential health and safety concerns has prompted some stakeholders to call for new, nano-specific regulations. Until now, governments have been hesitant to respond to such demands given the evolving state of the scientific art and limited international agreement as to what nanotechnologies or nanomaterials ‘are’. Despite these challenges, in November 2009 the European Union formally embraced the idea of specifically regulating the use of nanomaterials in cosmetic production. To achieve this objective, the Parliament and Council had to define what they meant by nanomaterials within the context of the adopted text in order to regulate them. It appears likely that other instruments will be similarly amended so as to include nano-specific provisions, including definitions. This article explores this policy shift within the European Union and the implications of the Parliament and Council’s stance at this stage due to the absence of a generally accepted definition within the international community.

Research handbook on climate change mitigation law

CONTENTS: 1. Editorial Introduction G. Van Calster, W. Vandenberghe and L. Reins 2. The Changing Architecture of International Climate Change Law Harro Van Asselt, Michael Mehling and Clarisse Siebert 3. Energy (a) Development of the Sustainability Aspects of EU Energy Policy Kim Talus and Sirja-Leena Penttinen (b) Greenhouse Gas Mitigation Measures in the US Electric Power Industry Joel B. Eisen (c) Reflections on the Chinese Carbon Market Christopher Tung 4. Transport (a) The mitigation of transports CO2 emissions in the EU: Policy successes and challenges Ian Skinner (b) Climate Change Mitigation in the Transportation Sector in the United States Laurel Berzanskis (c) Climate Transport Policy and Law in the Asia-Pacific Region Masahiko Iguchi and Hiroki Nakamura 5. Buildings (a) How do the European Union and the private sector pave the way to more sustainable buildings? Sophie Wattiaux (b) Energy Efficiency in the United States Albert Monroe (c) Climate Change and Buildings - An Asia-Pacific Primer Abhishek Rohatgi, Loi Tian Sheng Allan, Nahim Bin Zahur 6. Industry (a) Climate Change Mitigation in the Industrial Sector in the European Union Monica Alessi, Christian Egenhofer and Jorge Nunez Ferrer (b) An Overview of Climate Change Mitigation in the Industrial Sector of the United States Seema Kakade (c) How can the Asian industry contribute to climate change mitigation action? Noriko Fujiwara 7. Land use, land use change and forestry (a) Land Use, Land Use Change and Forestry - How to enter the climate impact of managing biospheres and wood into the EUs greenhouse gas accounting Peter Wehrheim and Asger Olesen (b) Land Use, Land Use Change and Forestry: United States Uma Outka (c) Land use, land use change and forestry: Asia-Pacific Bradley Evans 8. Waste management (a) Waste management in the EU Geert Van Calster (b) Challenges for controlling GHG emissions from U.S. solid waste management - A Summary of Federal and Exemplary U.S. State Efforts Jeff S. Allmon (c) Climate mitigation and waste management in the Asia Pacific Karen Hussey 9. Carbon trading (a) Blazing trail or flickering flame? Market mechanisms under the UNFCCC Darragh Conway (b) The EU Emissions Trading System: Frontrunner In Trouble Jorgen Wettestad (c) Carbon Trading in the United States Laurie Ristino and Katherine Hannon Michel (d) Market design and maturity in the Asia Pacific Eric Knight 10. Climate finance (a) Climate Finance in the European Union: Domestic and International Challenges David Belis (b) Towards Climate Compatible Development in Asia and Beyond - the Role of Official Development Assistance (Aiichiro Yamamoto 11. Climate change litigation (a) EU climate change litigation: all quiet on the Luxembourgian front? Sanja Bogojevic (b) Climate Change Litigation in the United States Michael Gerrard (c) Climate Change Litigation in Asia and the Pacific Jolene Lin 12. Climate change mitigation in the BRICS countries (a) Current status of mitigation policies in Brazil Ronaldo Seroa da Motta (b) Climate Change Mitigation in Russia: Foreign Policy, Environmental Action or Simple Economics? Anna Korppoo, Karl Upston-Hooper and Emilie Yliheljo (c) Climate Change Mitigation in India Nidhi Srivastava (d) Chinas transition to low carbon society : drivers and implementation strategies Jun Li (e) Climate change mitigation in South Africa Happy Masondo, Faith Rambau

For Me to Know and You to Find Out? Participatory Mechanisms, the Aarhus Convention and New Technologies

The Aarhus Convention lays down a legislative framework for participatory rights in environmental matters and potentially has wide-ranging application in and across the European Union and its Member States. This analysis identifies how these participation requirements can or may be imposed upon the European Commission as it sets about developing a regulatory framework for nanotechnologies. It then proceeds to identify a set of practical guidelines regarding public participation and nanotechnologies that could guide and assist the Commission in its current work on nanotechnology regulation. It is also suggested that these guidelines could provide an appropriate basis for assisting in the development of a suitable regulatory framework for new technologies in the future.

The Role of Private International Law in Corporate Social Responsibility

This contribution firstly reviews developments in the EU and in the United States on corporate social responsibility and conflict of laws. It concludes with reference to some related themes, in particular on the piercing of the corporate veil and with some remarks on compliance strategy, and compliance reality, for corporations.

Non-Contractual Liability as an Instrument for Regulating Nano and New Technologies – A Thorough Review Using National and European Union Tort Law

The novel properties yielded by nanoparticles’ physico-characteristics, and the benefits associated with them, have for some time now raised concerns over long-term health impact and potential risks. This article examines the suitability of non-contractual liability, as a regulatory instrument to deal with potential harm/damage that may be caused by engineered non-biodegradable/insoluble free nanoparticles, nanomaterials and products incorporating them, in a European context. It does so by employing an Environment, Health and Safety framework i.e. catering for reparation in occupational health and safety, product liability, and environmental damage scenarios. Delving into the rigours of tort law and case law in the EU, aiming to elucidate ius commune stances, the article explores the application of the OHS Framework Directive, the Product Liability Directive and the Environmental Liability Directive (albeit to a lesser extent). Insights are taken from cases (and regulation) primarily dealing with asbestos and genetically modified organisms.In the development of a regulatory framework for nanotechnologies, and other emerging technologies more generally, is non-contractual liability a good muscle to flex in the regulator’s stratagem? With all the unknowns that come with the ‘new’, is the law of (qausi) delict capable of meeting its aims - tempering, with caution, nanotechnologies’ use and proliferation? This article seeks to answer these questions in more than just general terms. In reviewing the detailed application of the law of torts in Europe, we offer in-depth insight into tort law’s ultimate (in)suitability for regulating new technologies.

Towards an innovation principle : An industry trump or shortening the odds on environmental protection

ABSTRACT This paper is a case study on how an industry association wrote a new principle on innovation and succeeded in introducing this principle into a number of European Union (EU) texts. The paper maps out how vested interests secured adoption of this (controversial) principle with an eye to influence future policy. To the best of our knowledge, this is the first time an industry association has successfully tried to introduce a new principle into the EU’s legal order. We try to assess what implications this could have on the EU’s existing legal order, with a particular emphasis on the impact this could have on the precautionary principle. The paper begins by examining both the political and the legal backdrop to the EU’s innovation agenda. We conclude by suggesting that a qualified innovation principle that balances reasonable risk-taking with a degree of responsibility could be an interesting new tool for the EU to guide its innovation policies.