In Europe, the production, use and disposal of NMs and hence of GRMs is regulated by a number of directives and regulations that apply to particular kinds of products. This is, for instance, the case of regulations for biocides, pesticides, cosmetics, veterinary products and pharmaceuticals. In addition, the REACH regulation concerning the registration, evaluation, authorization and restriction of chemicals (regulation EC 1907/2006) covers most of chemicals manufactured and imported to Europe with the aim to protect human health and the environment, whilst also enhancing industrial competitiveness. This regulation has been modified in the last years with the aim to also cover NMs. Therefore, it has profound implications at the economic, societal and scientific levels.
Once released into the environment, GRM due to their unique physicochemical properties, are likely to interact with other simultaneously present chemicals. Nevertheless, current risk assessments for regulatory purposes mainly rely on the evaluation of the effects of individual chemicals and they do not take into account the mixture toxicities. The present project addresses this issue and the information generated will have an impact on the knowledge about effects of GRM and about the combined NM-chemical effects on the organisms, which is crucial in the development of risk assessment approaches that contemplate the specificities of this kind of substances.
In addition, the generated information will facilitate the regulation and assessment processes of GRMs that are currently being produced or imported in Europe. This is strongly related with a positive economic impact of the project. At the same time, this project can have an important social impact by contributing to generate collective awareness about benefits and hazards of nanomaterials, helping therefore to an appropriate use of these substances.
Nowadays, there is an increasing social demand for the application of the 3Rs principle, replacement, reduction, refinement, in science and toxicology. As a reflection of this, the REACH regulation also encourages the use of alternative methods for obtaining chemical toxicity data. Therefore, this project also has a direct scientific and social impact related with the potentiation of the use of in vitro systems. 3D in vitro systems could generate reliable information about toxicity and mechanisms of toxic action of substances. Taking into account that 3D in vitro systems could be a good reflection of in vivo situations, the generated information could be evaluated in order to be directly applied in the risk assessment of NMs by regulatory bodies.
