Search

© 2019 The Authors. Highlights • 9 recommendations digest recent developments in regulatory environmental risk assessment. • Efforts are necessary to make the translation of ecotoxicology into regulatory decisions more open and transparent. • They require concerted and sustained action from a variety of sectors and stakeholders. • Better evidence will lead to better decisions, sustainable innovation and a healthier environment.

This report discusses a proposal fromthe Center for International Environmental Law(CIEL), ClientEarth and Friends of the Earth Germany (Bund) on the regulation of nanomaterials in the European Union. It discusses in particular, the proposal for a horizontal regulation on nanomaterials (also referred to as a nano-patch for existing legislation) that would fill in the regulatory gap on nanomaterials. The proposal goes beyond a review of the REACH text and encompasses all EU legislation relevant to nanomaterials. The proposed instrument would amend the REACH text with delimitation in scope to all areas relevant to nanomaterials (on the model of Regulation 1272/2008 on the classification, labelling and packaging of chemicals). The main aim of the regulation is to ensure that hazard, risk and exposure assessments for all forms and uses of such materials are adequately carried out and taken into consideration.

Background Risk assessment of chemicals and other agents must be accurate to protect health. We analyse the determinants of a sensitive chronic toxicity study, risk assessment׳s most important test. Manufacturers originally generate data on the properties of a molecule, and if government approval is needed to market it, laws globally require toxicity data to be generated using Test Guidelines (TG), i.e. test methods of the Organisation for Economic Cooperation and Development (OECD), or their equivalent. TGs have advantages, but they test close-to-poisonous doses for chronic exposures and have other insensitivities, such as not testing disease latency. This and the fact that academic investigators will not be constrained by such artificial methods, created a de facto total ban of academia׳s diverse and sensitive toxicity tests from most risk assessment. Objective To start and sustain a dialogue between regulatory agencies and academic scientists (secondarily, industry and NGOs) whose goals would be to (1) agree on the determinants of accurate toxicity tests and (2) implement them (via the OECD). Discussion We analyse the quality of the data produced by these incompatible paradigms: regulatory and academic toxicology; analyse the criteria used to designate data quality in risk assessment; and discuss accurate chronic toxicity test methods. Conclusion There are abundant modern experimental methods (and rigorous epidemiology), and an existing systematic review system, to at long last allow academia׳s toxicity studies to be used in most risk assessments.