Setting up as a bridge between regulatory science and policy
Table of contents
Significant progress has been achieved in relation to research regarding the safety of engineered nanomaterials and the transfer of this knowledge into regulation. Still, more needs to be done as nanotechnology reaches the market. To fill this gap, transdisciplinary risk governance is required based on a clear understanding of risk, its management practices and the societal risk perception by all stakeholders. It should propose and apply clear criteria for risk evaluation and acceptance and for transfer of acceptable risk. It should develop reinforced decision making tools incorporating those aspects and facilitate risk communication to relevant stakeholders, including industry, regulators, insurance companies and the general public.
- Data and information management and framework tools with regard to the safety of nanomaterials for risk assessment, hazard and exposure, human health and environment, and risk mitigation including regulatory aspects of safe-by-design;
- Responsible communication with stakeholders and the civil society based on good quality information and valuable feedback;
- Plans for future scientific and regulatory research paying attention to social, ethical and environmental aspects, to achieve completeness, consistency, maximum synergy of actions and international cooperation;
- Mechanisms to monitor progress in several industrial sectors and to revise plans.
(reproduced from the H2020 call text Risk Governance of nanotechnology (RIA), TOPIC ID: NMBP-13-2018)
A crucial element related to risk governance is the establishment, by consensus, of a set of scientifically reliable and regulatory relevant technical guidelines and good practices documents. Ideally such guidelines and documents should be aligned to the requirements for guidance and standards of international organisations such as OECD, ISO and CEN. Agreed standardised test guidelines and guidance documents are needed to allow reliable and relevant safety testing of nanomaterials regarding both human health and the environment. In particular, the OECD guidelines for chemicals’ notification and registration under REACH need adaptation for nanomaterials from characterisation of materials and exposure, to potential for persistence, bioaccumulation and toxicity.
- Outline specific research actions of regulatory research nature to cover existing gaps in OECD test guidelines and guidance documents development;
- Establish integration of other public and private resources (funding or labour) to develop and validate new OECD test guidelines and OECD guidance documents;
- Establish maximum synergy of actions across industrial sectors and international cooperation;
- Support the completion of the elaborated documents by the relevant international organisations involving OECD Member States and relevant EU agencies;
- Establish very close cooperation with Member States, OECD, BIAC, JRC, ECHA, EU and Member State agencies to act as leads and co-leads for the test guidelines and guidance documents to be developed.
(reproduced from the H2020 call text In support of documentary standards (CSA), TOPIC ID: NMBP-34-2019)
The NanoHarmony project supported the development of OECD Test Guidelines and Guidance Documents for eight endpoints where nanomaterial-adapted test methods have been identified as a regulatory priority. Based on this work, it provides recommendations to address issues, which might jeopardise keeping pace with new scientific developments, to ensure engagement of all the relevant stakeholders, not least those in the academic community, and to make the process of TG development more effective.