Regulation & Product Approval
Whilst nanomaterials and nanoproducts are increasingly subjected to regulatory requirements, NIA is committed to foster a constructive discussion between nanotechnology industries, strategic placeholders and regulators.
Through diverse activities and projects, the association promotes a wholesome dialogue for a responsible enforcement of regulations and a smooth product approval process. NIA’s action is driven by its participation as a lead-representative of the Business and Industry Advisory Committee (BIAC) to the OECD Working Party on Manufactured Nanomaterials (OECD WPMN). In addition, the association gives a major importance to the development of international standards in the area of nanotechnology.
NIA is devoted to assist its members along product approval processes and other regulatory requirements. In doing so, NIA provides its technical and scientific support on nanotechnologies and operates to improve the functioning of REACH, the overarching European regulation for chemicals. In this respect, the association participates in the ambitious REACH-nano Help Desk, and played an active role on the REACH Implementation Plans on Nanomaterials (RIP-oNs). Members can find out more on NIA's individual REACH-nano Support Service under the NIA REACH-nano Representation section.
Activities and Projects in our objective area 'Regulations and Product Approval' are listed below.
The objective of the caLIBRAte project is to establish a state-of-the-art versatile Risk Governance framework for assessment and management of human and environmental risks of MN and MN-enabled products. The framework will be a web-based “system-of-systems” linking different models and methods for:
ProSafe has been designed to coordinate and support the aims of EU Member and associated states in their EU and international efforts (OECD, COR, EU-USA) regarding risk assessment, management and governance by streamlining data acquisition, collection and management on regulatory orientated toxicology testing of nanomaterials, exposure monitoring, LCA, and disposal and treatment of waste nanomaterials.
One of the greatest challenges facing regulators in the ever changing landscape of novel nano-materials is how to design and implement a regulatory process which is robust enough to deal with a rapidly diversifying system of manufactured nanomaterials (MNM) over time. Not only does the complexity of the MNM present a problem for regulators, the validity of data decreases with time, so that the well-known principle of the half-life of facts (Samuel Arbesman, 2012) means that what is an accepted truth now is no longer valid in 20 or 30 years time.
As part of its support and integrated service to its Members, the NIA prepare its presence to the CASG-nano and the ECHA Stakeholder Group in close cooperation with its Members, in order to allow for appropriate input from its Members on relevant topics on the meeting agendas, and follow up with detailed minutes.
The aim of REACH-nano Help Desk (external link)is to develop a web-based REACH toolkit to support the chemical safety assessment of nanomaterials. The toolkit will take into account the needs and specifications of end-users and stakeholders, including advanced functionalities that will support industry and authorities to fulfil their tasks under REACH. The REACH-nano Help Desk project supports the implementation of the REACH regulation for nanomaterials.
The innovative and economic potential of Manufactured Nano Materials (MNMs) is threatened by a limited understanding of the related EHS issues. While toxicity data is continuously becoming available, the relevance to regulators is often unclear or unproven. The shrinking time to market of new MNM drives the need for urgent action by regulators. NANoREG is the first FP7 project to deliver the answers needed by regulators and legislators on EHS by linking them to a scientific evaluation of data and test methods.
The OECD Working Party of Manufactured Nanomaterials (OECD WPMN), established in 2006 under the OECD Chemicals Committee, focuses on issues related to nanomaterials impacting human and environmental health and safety; it comprises both governmental delegates from those ministries and agencies, which are responsible for the human and environmental health and policies and regulation, as
The two RIP-oN projects (RIP-oN2 and RIP-oN3) are independent projects funded by the Institute for Health and Consumer Protection (IHCP) of the European Commission’s Directorate General Joint Research Centre (JRC) to a consortium led by SAFENANO (Institute of Occupational Medicine), and including the Nanotechnology Industries Association,