Use of new scientific developments in regulatory risk assessments: Challenges and opportunities


  • This article represents 1 of 12 commentaries from selected representatives of the international scientific community, industry, and regulatory agencies, on the need for substantial changes and improvements in Ecological Risk Assessment. The series of articles is the follow-up to the Special Session “New Challenges in Ecological Risk Assessment,” held at the 6th SETAC World Congress/SETAC Europe 22nd Annual Meeting in Berlin (May 2012) and the opinion of the Scientific Committees of the European Commission, DG SANCO (SCHER, SCHENIR, SCCS) on “Addressing the New Challenges for Risk Assessment.”


Since the 1990s, science based ecological risk assessments constitute an essential tool for supporting decision making in the regulatory context. Using the European REACH Regulation as example, this article presents the challenges and opportunities for new scientific developments within the area of chemical control and environmental protection. These challenges can be sorted out in 3 main related topics (sets). In the short term, the challenges are directly associated with the regulatory requirements, required for facilitating a scientifically sound implementation of the different obligations for industry and authorities. It is important to mention that although the actual tools are different due to the regulatory requirements, the basic needs are still the same as those addressed in the early 1990s: understanding the ecological relevance of the predicted effects, including the uncertainty, and facilitating the link with the socio-economic assessment. The second set of challenges covers the opportunities for getting an added value from the regulatory efforts. The information compiled through REACH registration and notification processes is analyzed as source for new integrative developments for assessing the combined chemical risk at the regional level. Finally, the article discusses the challenge of inverting the process and developing risk assessment methods focusing on the receptor, the individual or ecosystem, instead of on the stressor or source. These approaches were limited in the past due to the lack of information, but the identification and dissemination of standard information, including uses, manufacturing sites, physical-chemical, environmental, ecotoxicological, and toxicological properties as well as operational conditions and risk management measures for thousands of chemicals, combined by the knowledge gathered through large scale monitoring programs and spatial information systems is generating new opportunities. The challenge is liking predictions and measured data in an integral “-omic type” approach, considering collectively data from different sources and offering a complete assessment of the chemical risk of individuals and ecosystems, with new conceptual approaches that could be defined as “risk-omics based” paradigms and models. Integr Environ Assess Manag 2013;9:e85–e91. © 2013 SETAC