Ecotoxicological risk assessment in the context of different EU regulations

Abstract

For an appropriate environmental risk assessment, it is necessary to perform a set of ecotoxicological tests in the different environmental compartments. The number and type of ecotoxicological assays that must be performed to introduce a substance, mixture, or product into the market will depend on the properties and characteristics of the chemical itself, its persistence, bioaccumulation, toxicity, and ecotoxicity. In addition, the intended use also determines the type and number of tests to be performed. During the last decades, the European Union has approved many regulations and directives on chemicals, such as those under REACH Regulation, Biocidal Products, Plant Protection Products, Human and Veterinary medicines, Nanoforms, etc. All of them are subjected to rigorous legislative and regulatory frameworks to ensure human health and the environment and, in some circumstances also, animal health. In addition to these laws focused on the chemicals, there are other crosscutting laws, like the Water Framework Directive (2000/60/EC), Directive 2010/63/EU on the protection of animals used for scientific purposes, or Directive 2004/10/EC on good laboratory practice, which are continuously mentioned in the directives and regulations on chemicals. Finally, the European Union is currently working to implement a strategy for a nontoxic environment, paying special attention to promoting innovation and the development of sustainable substitutes including nonchemical solutions.