regulatory preparedness, european
© Oleg Dudko

Monique Groenewold discusses how modern innovation requires regulatory preparedness in risk governance, especially for nanotechnology

Adriënne J.A.M. Sips1, M. Groenewold1, T. van Teunenbroek2
1 National Institute for Public Health & the Environment, The Netherlands
2 Ministry of Infrastructure and Water Management, The Netherlands

Main message

The European Green Deal1 (GD) defines the Commission’s commitment to tackling climate change and environmental-related challenges, setting ambitious goals like a zero-pollution approach for a toxicity-free environment. Major investments in cutting-edge research and innovation and the new Framework Programme Horizon Europe, based on modern innovation principles, are put in place to achieve these transformative objectives. The work of three collaborating H2020 projects (Gov4Nano, NANORIGO, RiskGONE)2 on risk governance underscores why an integrated approach on technological innovation and regulatory science development programmes is pivotal for achieving the goals of the GD. In our opinion, synergy between the Horizon Europe programme and the European Better Regulation Agenda must be improved.

Disconnect between innovation and regulations

Key Enabling Technologies like nano-technology are thought critical to reaching some of the transitions and goals of the European GD, like the role of nanotechnology in solar and battery technologies. However, the adequacy of safety regulation for nano-technology is still under debate3.

Innovation policies are focussed on promoting technology development, whilst lacking a simultaneous, proportional push for appropriate risk governance. This resulted in a situation of ongoing uncertainty about safety of production processes, products and waste handling. The lack of a synchronised approach has led to risk governance that is increasingly lagging behind innovation.

Risk governance in changing innovation systems

The European Commission states in its GD that new technologies, sustainable solutions and disruptive innovation are critical to achieve the objectives of the GD1. It aims for synchronicity of all policy levers: regulation and standardisation, investment and innovation, national reforms, dialogue with social partners and international cooperation. Currently, the connection of adequate regulation and standardisation development to European research and innovation programmes like H2020 and Horizon Europe is undefined. This is a unique situation, since regulation and standardisation determine market introduction and acceptance of innovations.

This disconnect is in line with classic innovation policy, aiming at economic growth and improving the competitive position through knowledge development and innovations. The GD promotes modern or mission driven innovation policy; putting increased emphasis on efficient transfer of knowledge, stimulation of collaboration and focussed opportunities of funding. A combination of changes at the level of technology development, governance systems and roles and activities of stakeholders involved in governance systems is therefore mandatory in these new innovation policies4.

Innovators often regard regulations, especially uncertainty about regulatory acceptance, as a hurdle for verification of their ideas. This situation diminishes the potential of innovation as stimulus for economic growth as well as stimulus to address societal issues.

Mission driven innovation therefore needs co-development of regulatory requirements and testing guidelines and standards to test against. Upcoming risk governance concepts such as Safe-by-Design are welcomed but will never replace regulation (REACH, consumer products safety directive, etc).

Safe Innovation Approach: Nanotechnologies as example

In a series of H2020 projects on nanosafety (NANoREG, NanoReg2, and ProSafe) a proactive, integrated approach, called the Safe Innovation Approach (SIA) was developed. SIA focuses on minimising the gap between nanotechnology development and development of appropriate regulation and standardisation in phase. It seeks to enhance the ability of all stakeholders to address safety assessment of innovations in a robust yet agile manner.

SIA combines a) the Safe-by-Design (SbD) concept, which recommends industry to integrate safety considerations as early as possible into the innovation process, and b) the Regulatory Preparedness (RP) concept which aims to improve anticipation of regulators in order that they can facilitate the timely development of adaptable (safety) regulation5. For example, for the ambition to reduce air pollution and CO2 emission, innovation in battery technology, new materials and production technologies has to be developed. These new materials are characterised by complex or innovative structures and composition. To prevent delays in development of technologies as well as concluding on regulatory acceptance it is worth to check prospectively whether the new developments in the materials sciences are still covered by the current framework for (chemical) risk regulation.

Necessity to synchronise Horizon Europe and Better Regulation Agenda

Horizon Europe is designed to address the needs for technological innovations supporting the GD. It is unthinkable to achieve these ambitious and transformational objectives, without appropriate regulations and risk governance.

In 2015 the European Commission’s Better Regulation Agenda was initiated with the Regulatory Fitness and Performance (REFIT) Platform6 as advisors to the Commission. The REFIT Platform7 advised, amongst others, specific actions to enhance the efficiency, transparency and legal certainty for the actors involved in the development of harmonised standards. Actions dealt with improvement of the practical implementation of the European standardisation system and with securing that this system meets the challenges of rapidly evolving technological developments.

In our opinion, the role of technological innovations as pivotal propeller and supporter of ambitions of the GD can only be fulfilled when simultaneously supported by the Better Regulation Agenda. Developments in the field of nanotechnology taught us that appropriate regulation and standardisation are indispensable for successful innovation, but only when a risk governance system ensuring all steps from timely and dedicated knowledge development up to implementation in regulation, is in place. The Malta Initiative8 demonstrates the need for action to make legislation enforceable, ensuring that essential test, measurement and verification procedures (with initial focus on nanomaterials) are available for innovative technologies and their products.

The ongoing H2020 projects Gov4Nano, RiskGONE and NANORIGO, developing insights for a risk governance system in support of development of nanotechnologies, could deliver valuable input for improved integrated approaches between Horizon Europe programmes and activities under the Better Regulation Agenda.

1 https://ec.europa.eu/info/publications/communication-european-green-deal_en
2 www.gov4nano.eu; www.nanorigo.eu; www.riskgone.eu
3 https://echa.europa.eu/regulations/nanomaterials
4 Marko Hekkert et al., “Maatschappelijke missies en innovatiebeleid: hoe gaan ze samen? ”, Me Judice (http://www.mejudice.nl/) , 13, november 2018
5 Lya G. Soeteman-Hernandez, et al., Materials Today Communications, https://doi.org/10.1016/j.mtcomm.2019.100548
6 REFIT’s mandate has ended in november 2019; to be continued by a new ‘Fit for Future’ platform
7 https://ec.europa.eu/info/sites/info/files/2018-annual-burden-survey_en_0.pdf, page 76
8 https://www.bmu.de/en/topics/health-chemical-safety-nanotechnology/nanotechnology/the-malta-initiative/ 

*Please note: This is a commercial profile

Contributor Profile

Coordinator of H2020 NMBP-13 Gov4Nano
National Institute for Public Health and the Environment (RIVM), The Netherlands
Phone: Tel: +31 6 136 72 948
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