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 Guidance Documents

These documents have been developed with the participation of many stakeholders: Industry, Member States and NGOs.

Reference name: caLIBRAte Factsheets
Description: Based on the mismatches from the stakeholder assessment performed previously (See Fact sheet Selecting environmental hazard, exposure and risk assessment) an expert workshop was held to investigate mismatches between the top 5 tools (as a result from this stakeholder assessment). The workshop’s goal was to identify mismatches, and provide innovative solutions which help model owners to overcome these mismatches and increase the applicability domain of their tool.
URL(s): Guidance for implementation of existing HRA models at appropriate stages in the production process (04.10.2019)
Reference name: Identification of nanomaterials through measurements (JRC Policy Report)
Description: This document aims to support the implementation of the European Commission’s Recommendation on the definition of nanomaterials (2011/696/EU). It is a follow-up of a previous JRC Science for Policy Report on concepts and terms used in the definition. The present report addresses the identification of nanomaterials by measurements and discusses options and points to consider when assessing whether a particulate material is a nanomaterial or not according to the definition of nanomaterials. H. Rauscher, A. Mech, N. Gibson, D. Gilliland, A. Held, V. Kestens, R. Koeber, T. P. J. Linsinger, E. A. Stefaniak
Document(s): Download KJNA29942ENN.PDF (22.01.2020)
URL(s): Identification of nanomaterials through measurements (22.01.2020)
Reference name: PGNanoRIG: Framework and Guidance
Description: This document provides guidance on the caLIBRAte Phase-Gate Nano-Risk Innovation Governance (PGNanoRIG ) Framework and implemented the caLIBRAte Stage-Gate Nano-Risk Innovation Governance tool included in the caLIBRAte Nano-Risk Governance Platform. The document gives basic principles and recommends generic project activities and aspects that to be considered as part of a manufactured nanomaterial and/or nanoproduct innovation project. The guidance is applicable to all Phase-gates concerning governance, risk assessment, risk management of nanotechnologies, different nanomaterial and nanotechnology innovation projects.
Document(s): Download PGNANORIG FRAMEWORK AND GUIDANCE_V1.1ORIG.PDF (08.09.2020)
Reference name: EC: Definition of a nanomaterial
Description: The EU adopted a definition of a nanomaterial in 2011 (Recommendation on the definition of a nanomaterial (2011/696/EU)). Its provisions include a requirement for review "in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased".
URL(s): EC: Definition of a nanomaterial (28.09.2020)


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