Related Experiment Video
Updated: May 11, 2026

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
Published on: February 10, 2023
Use of new scientific developments in regulatory risk assessments: challenges and opportunities
1European Chemicals Agency, Annankatu, Helsinki, Finland. Jose.Tarazona@echa.europa.eu
Abstract:
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.
Related Concept Videos
Drug Control Governance: Regulatory Bodies and Their Impact
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Drug Regulation
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Global Regulatory Systems
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...