Selected Commission studies related to regulatory management of nanomaterials
As the 2nd regulatory review indicated that the whole exercise is expected to be repeated in several years, DG ENV commissioned a study to support such a review. Also due to delays in some of the actions of the 2nd regulatory review (see Definition , REACH Annex change), the Commission has decided not to formally launch a 3rd regulatory review on nanomaterials. The study performed by Ricardo Energy & Environment, in partnership with subcontractors Milieu Consulting and the Technical University of Denmark (DTU) and published in November 2016 however still provides a very useful update, as all the environmental regulations are revisited and new implementation experience is taken into account. The study explores, albeit superficially, also the aspect of classification and regulation of advanced materials.
In 2011, as part of the second review of regulatory aspects of nanomaterials (in preparation), DG Environment commissioned a study "Review of Environmental Legislation for the Regulatory Control of Nanomaterials" that was conducted by Milieu. The objective of the study was to review environmental legislation for waste, water and other relevant acts as regards their legal coverage of nanomaterials and, where possible, implementation on the ground. The second objective was to identify and describe legislative and implementation gaps in environmental legislation, including details on whether gaps relate to a lack of legal coverage, limitations in technical capacities or dependences on other legislation.
A second study looked in a more detailed way into the aspects of environmental exposure to nanomaterials. "Environmental Exposure to Nanomaterials - Data Scoping Study" compiled and evaluated available information on the exposure to nanomaterials in the EU, and investigated all potential sources of information from direct monitoring data to the necessary input required in modeling estimations. The reports cross-linked this information with current regulatory requirements under environmental legislation and provided a number of recommendations to improve the knowledge base on exposure, required for adequate risk assessment and management of nanomaterials.
There are some further thematic studies that touch on the emerging issue of nanomaterials and the environmental legislation, e.g. "Coherence of Waste legislation".
DG Environment commissioned this study on the 'Development of an inventory for consumer products containing nanomaterials' which was taken forward by the Rijksinstituut voor Volksgezondheid en Milieu (RIVM) throughout the course of 2011. (The report does not necessarily constitute the views of the European Commission)
The report covers technical aspects of developing a methodology to identify such products on the market. It also examines the challenges associated with the development of a database - including both searchability and technical IT issues - and discusses other issues of relevance, such as ongoing maintenance.
Recommendations are presented on how to set up a comprehensive database, and on those relevant organisational and practical issues that would accompany potential implementation.
In 2010 DG Environment initiated the project "Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information". The project was managed by the European Commission's Joint Research Centre (JRC) in close collaboration with ECHA, and was divided in two separate tasks.
Task I entailed the identification of REACH registration dossiers that cover nanomaterials, the scientific assessment of the information on nanomaterials contained in these dossiers, and proposing how potential cross-cutting shortcomings can be addressed. Task I was completed in March 2012 (Final Report Task I).
Task II was completed in January 2013 and focused on assessing potential economic and environmental consequences of the technical proposals made in Task I.
The REACH Implementation Project on Nanomaterials (RIPoN, 2009) provided advice on key aspects of the implementation of REACH with regard to nanomaterials concerning Information Requirements and Chemical Safety Assessment.
The two final reports are available here:
Based on the scientific and technical state of the art recommendations in these reports ECHA on 30 April 2012 published three new appendices, updating Chapters R.7a, R.7b and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). These three new appendices are recommendations for registering nanomaterials.
A third report of the RIPoN project relates to Substance Identity. The final report is available but as it was not possible to reach consensus amongst the experts on the recommendations, further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.