A methodological approach which includes conceptual developments, methodological aspects and software tools have been developed in the Spanish context, based on the BIOMASS "Reference Biospheres Methodology". The biosphere assessments have to be undertaken with the aim of demonstrating compliance with principles and regulations established to limit the possible radiological impact of radioactive waste disposals on human health and on the environment, and to ensure that future generations will not be exposed to higher radiation levels than those that would be acceptable today. The biosphere in the context of high-level waste disposal is defined as the collection of various radionuclide transfer pathways that may result in releases into the surface environment, transport within and between the biosphere receptors, exposure of humans and biota, and the doses/risks associated with such exposures. The assessments need to take into account the complexity of the biosphere, the nature of the radionuclides released and the long timescales considered. It is also necessary to make assumptions related to the habits and lifestyle of the exposed population, human activities in the long term and possible modifications of the biosphere. A summary on the Spanish methodological approach for biosphere assessment are presented here as well as its application in a Spanish generic case study. A reference scenario has been developed based on current conditions at a site located in Central-West Spain, to indicate the potential impact to the actual population. In addition, environmental change has been considered qualitatively through the use of interaction matrices and transition diagrams. Unit source terms of Cl-36, Se-79, Tc-99, I-129, (CS)-C-135, Ra-226, Pa-231, U-238, Np-237 and Pu-239 have been taken. Two exposure groups of infants and adults have been chosen for dose calculations. Results are presented and their robustness is evaluated through the use of uncertainty and sensitivity analyses. (C) 2008 Elsevier B.V. All rights reserved.