Research priorities relevant to development or updating of nano-relevant regulations and guidelines
Creators: name: Stone, Vicki
name: Önlü, Serli
name: Bergamaschi, Enrico
name: Carlander, David
name: Costa, Anna
name: Engelmann, Wilson
name: Ghanem, Antoine
name: Hartl, Sonja
name: Hristozov, Danail
name: Scott-Fordsmand, Janeck J.
name: Jensen, Keld Alstrup
name: von der Kammer, Frank
name: Sergent, Jacques-Aurelien
name: Sharma, Monita
name: Dusinska, Maria
name: Nowack, Bernd
name: Sayre, Phil
name: Vogel, Ulla
name: van Tongeren, Martie
name: Vázquez-Campos, Socorro
name: Wohlleben, Wendel
Publisher: name: Zenodo
Year: 2016
Subjects: Nanomaterials
Regulations
Policy
Research

description: The purpose of this document is to identify complete and ongoing activities associated with development of appropriate regulations relevant to promoting the safety of nanomaterials (NM). In doing so the document identifies research areas or priorities that need to be addressed further in order to facilitate this process.

The use of a diverse array of NM in wide array of consumer, industrial and medical applications has led to an increased interest in improving our understanding of issues pertaining to their safe use. The European Commission has funded many projects during the Framework programme 7 which initially set out to identify whether there were significant safety issues relating to nanomaterials (e.g. NANOIMMUNE, NANOGENOTOX, ENPRA, MARINA, NANOSOLUTIONS, MARINA, NanoTEST). Based upon the evidence generated by these studies, EU projects have now moved on to develop strategies for risk assessment and decision making (e.g. MARINA, SUN, GUIDENANO, NANOSOLUTIONS) and to identify whether nanomaterials are adequately regulated by current European legislation (e.g. NANoREG and RIPoN). These activities are being further enhanced in Horizon 2020 with the funding of PROSAFE, NANoREG II and other new projects.

There are already several regulations in EU that specifically mention nanoparticles or nanomaterials. The first EU regulation mentioning nanotechnology was the Food Additive regulation (EC) No 1333/2008. Since then, other adapted regulations have been incorporated in areas relevant to food, cosmetics, packaging and biocides. More details are provided below.

However, there remain significant gaps in knowledge and procedures that need to be addressed in order to generate appropriate and proportionate regulation for nanomaterials that is informed by a sound evidence base. The following short report outlines the current regulatory landscape as it pertains to nanomaterials and then identifies the additional major areas that need to be considered, pointing out relevant activities that have or are being conducted in relation to each, but highlighting those for which more work is needed.

Some of the proposed work is academic research, while a proportion is related to standardisation/validation, and the remainder involves integration of evidence with social and political considerations in order to better regulate nanomaterials. The major areas or knowledge gaps to be addressed are presented as hexagons in a diagram that provides an indication of how they might be prioritised over time in order to achieve this final goal. However, the diagram is flexible and can be updated as knowledge is acquired and the questions are adjusted. For each major area to be addressed a short narrative has been generated to further explain the relevance of the major area and to reference relevant activities that contribute to this major area.