Thematic studies for Review of REACH
REACH contribution to the development of emerging technologies
This study assessed current and further possibilities of REACH-CLP to effectively foster innovative development, enhanced commercialisation and speeded uptake of products of emerging technologies to ensure their contribution to addressing the EU 2020 challenges. It also made recommendations for areas in which improvement could be made.
Survey to nanotechnology companies as an example area of emerging technologies in Europe and in-depth interviews with industry and public authorities.
Workshop, December 2011
Final report [4 MB]
Final report - Appendices [2 MB]
Highlights of the consultants findings
The regulatory uncertainties (e.g. testing costs and authorisation) and lack of capital were considered the main challenges in bringing nanomaterials to market in Europe. The main REACH and CLP impacts on products of emerging technologies were considered to be administrative burden and information requirements, as well as negative effect to time-to-market and marginal cost structure.
Large variations exist in the registrations costs of substances with nanomaterial forms. The compliance costs are largely taken out of R&D resources in smaller companies. In case companies are not able to transfer them to the product price - typically seen as a problem for SMEs - it may affect the time to market of products and their competitiveness in the global market.
Few companies had applied the Five year registration exemption for Process and Product Oriented Research and Development. Accordingly, there is a clear need to ensure that especially smaller companies will be aware in good time of what support is available and what exactly will be needed, when and in which steps etc. enabling companies factor REACH and CLP effectively into the innovation process and long-term budget planning. Also specific funding instruments could help especially small companies to comply with REACH and ensure innovations overcome the chasm and become mainstream market.
The nanotechnology companies were asked about potential changes to legislation They considered, mainly due to administrative burden and time-to-market, the possible modifications of “Considering all NMs as new substances”, “Chemical Safety Report with exposure assessment for all registered NMs” and “Notification requirement for all NMs placed on the market on their own, preparations or in articles” mainly negative for the enhancement of competitiveness and innovation, while “Simplified registration also for NMs manufactured or imported in quantities of less than one tonne” a third of manufacturers considered the effect negative and a fourth indicated no effect. All of them would most affect small companies.
A set of six recommendations on key policy options put forward by the consultant were:
I Reduce uncertainties related to regulatory aspects (e.g. testing costs, authorisation)
II Streamline information/testing requirements between sectoral legislations
III Substances produced by emerging technologies should not be treated more stringently than any other substances (or forms of substance)
IV Strengthen the integration of REACH provisions into the Research & Development & Innovation processes
V Enhance market uptake of safer chemicals
VI Ensure affordable means for financing REACH compliance in Research & Development & Innovation process.
Enterprise and Industry