title: Limits and prospects of the "incremental approach" and the European legislation on the management of risks related to nanomaterials.
abstract: Scientific uncertainty involved in evaluating potentially harmful properties of engineered nanoparticles complicates and hampers the implementation of proportionate regulative measures by legislators. The European Commission has adopted a so-called "incremental approach", which focuses on adapting existing laws to regulate nanotechnologies, and therefore this paper aims to test the effectiveness of the "incremental approach". Three commercially available products containing fullerenes (C(60) and carbon nanotubes) were analysed in a life cycle perspective in order to (1) map current applicable regulations, (2) analyse their applicability to nanomaterials, (3) identify their gaps, and (4) suggest proper solutions. After mapping the life cycle of the three products, we analysed applicable regulations in the order in which they became relevant in their life cycle, i.e.: The Safety at Workplace Directives. Directive 61/1996 on the Integrated Pollution Prevention and Control. The European Union's Directive on the Registration, Evaluation, Authorization and Restriction of Chemicals, and The Waste Management Directives. It was found that the applicability of environmental laws is limited due to difficulties in generating sufficient data on the nanomaterials residing in the products according to their life cycles. Further, metrology tools are unavailable; thresholds are not tailored to the nanoscale; and toxicological data and occupational exposure limits cannot be established with existing methodologies. We conclude that the "incremental approach" can only be applicable with the implementation of due amendments.
authors.affiliation: Institute of Environment & Resources, Technical University of Denmark, Building 113, NanoDTU Environment, DK 2800 Kgs. Lyngby, Denmark.
authors.forename: Antonio
authors.initials: A
authors.lastname: Franco
authors.forename: Steffen Foss
authors.initials: SF
authors.lastname: Hansen
authors.forename: Stig Irving
authors.initials: SI
authors.lastname: Olsen
authors.forename: Luciano
authors.initials: L
authors.lastname: Butti
mesh_terms: D004781:Environmental Exposure / Q000331:legislation & jurisprudence*; D004785:Environmental Pollutants / Q000633:toxicity; D004787:Environmental Pollution / Q000331:legislation & jurisprudence; D005062:European Union; D037741:Fullerenes / Q000633:toxicity*; D006801:Humans; D053758:Nanoparticles / Q000633:toxicity*; D036103:Nanotechnology / Q000331:legislation & jurisprudence*; D016273:Occupational Exposure / Q000331:legislation & jurisprudence; D018570:Risk Assessment / Q000331:legislation & jurisprudence; D017751:Safety Management / Q000331:legislation & jurisprudence* / Q000379:methods; D018505:Waste Management / Q000331:legislation & jurisprudence
chemical_list: D004785:Environmental Pollutants; D037741:Fullerenes