Joint EU & MS activity on the next phase of research in support of regulation 'NANOREG II'

Specific challenge: Regulation of the nanomaterials market evolves parallel to technology development and societal requirements. The running project NANOREG addresses regulatory research for the quantification of hazard and exposure, a necessary step in regulatory risk assessment. The commercial viability of nanomaterial development in the EU is conditional on new nanomaterials meeting current and future regulatory requirements and should be based on cutting-edge technology with regard to the next steps of risk management and risk mitigation. Demonstration of integration of such technology into the design of new nanomaterials and products and their applications is a major challenge and the main objective of this joint action.

Scope:

(1)  To develop and demonstrate Safe-by-Design regulatory approaches for nanomaterial development.

(2)  To validate the tools and methodology, as well as their background data-sets, that will lead to the manufacture of novel, inherently safe nanomaterials.

(3)  To address barriers for the application of Safe-by-Design as standard industry practice.

The project should seek to establish principles for grouping strategies for nanomaterials according to their assumed modes of toxicological action for regulatory purposes. Out of each group, a few representative materials should be selected and a toxicological profile shall be assessed. The scope may include novel materials, coated materials and self-assembled materials, nanomaterials with different surface functionalisation, and third generation particles. The project should take into account future dossier requirements under REACH, or other related EU legislation, to limit the required additional information, especially animal testing, to the essential minimum. Active participation of industrial partners is strongly encouraged to establish strong industry-authorities collaboration and the partners should conclude a results communication policy before the start of the project. This collaboration should be complemented by solid mechanisms networking state and private laboratories in nanotechnology toxicity testing and exposure control.

Activities expected to focus on Technology Readiness Level 5.

The Commission considers that, in addition to requested EU contribution between EUR 6 and 10 million, proposals should gather sufficient resources from EU Member States and Associated Countries to allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. No more than one proposal will be funded.

Expected impact: The project is expected to:

    Strengthen seamless collaboration among authorities of the EU Member States and Associated Countries with regard to the knowledge required for appropriate risk assessment and management in this field given the fast development of the market;

  Bring together the activities of national authorities responsible for consumer and worker protection, public health, and the environment including chemical safety and all other relevant authorities covering the whole value;

   Coordinate regulatory oriented activities of, or cooperate with, other on-going projects on toxicity testing, on decision making for material characterisation and testing protocols, and for data management; and

  Integrate its work with OECD-WPMN, CEN[1] and ISO, and other European funded projects in the nanosafety cluster.

Type of action: Research and Innovation Action

[1] See Mandate M/461 addressed by the European Commission to CEN/CENELEC and ETSI. http://www.cen.eu/cen/Sectors/Sectors/Nanotechnologies/Documents/M461.pdf