Abstract: There are many promises, but also potential risks, concerning the evolving nano-industry. For maintaining a high level of protection for the environment and consumer in this area of industry a thorough evaluation of the traditional approaches to risk assessment and management is needed. To this end, this article analyses the substance-oriented approach of the REACH Regulation as the main instrument for environmental and consumer protection and compares it to the Pesticide Directive and the Biocidal Products Directive, both of which are based on a product-oriented approach. The results challenge current assumptions that the traditional regulatory approaches are sufficiently equipped to provide for adequate risk assessment towards the new properties of nanomaterials.
LIVING WITH UNCERTAINTY?
The news is spreading: nanomaterials offer a wide range of new properties of substances and thus lead to new opportunities in the development of products and in their marketing.1 It is not an overestimate to compare the potentials of this market to the IT market, especially considered in terms of the evolution of the personal computer from the former computer centres of the 1960s to the current high-performance laptops. If the development will describe a similar exponential curve,2 one might imagine the dimensions to which the future exposition to nanomaterials of consumers and the environment could reach.
Nanomaterials are already in use in various aspects of the life sciences. In materials science advantage is taken of nanocomposites because of their mechanical properties which are different from conventional microstructures.3 Nanotopographies offer new potential concerning adhesion, tribiology, optics and electronic behaviour in surface science and surface engineering. A new branch of novel surface and size-dependent chemistry is on the rise; just as in biological sciences advances are being reached in drug design and targeting. The new properties are not restricted to research and development but find their way into consumer products, especially cosmetics and sunscreens, fibres and textiles, medicinal products, foodstuffs, dyes, fillers, paints, colloids and emulsions.
At the same time, the new properties bring new risks as full knowledge of their potential is far from being achieved.4 And the more promising the new properties seem to be, the more concern is raised about detrimental effects. Part of the new properties based on their specific scale is that nanomaterials might penetrate the blood-brain barrier as well as the blood-lungs barrier.5 In particular, the question of cumulative effects provides a new dimension. With this potential for hazard, regulatory authorities have reason to fear an 'asbestos 2.0' scenario, in which a considerable number of products containing nanomaterials might have to be recalled from the market. There is already some evidence that certain nano tubes might have properties similar to asbestos.6 Thus, one cannot be too sure for how long market participants, especially consumers, will be ready to accept living under this Damocles' sword of uncertainty.
Are the existing EU regimes sufficiently equipped to deal with the risks of nanomaterials or do we need specific 'nanolaws'? The European Commission believes the existing regulatory framework to be adequately equipped to deal with risk assessments of nanomaterials and only minor modifications to be necessary Consequently, the Commission focuses on a two-tiered strategy, building up competence for risk evaluation and assessment while engaging in a transparent discourse with all stakeholders, including consumers and their organisations.