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Posted: Jun 28, 2011

Cefic's first Nanotechnology and REACH workshop a success

(Nanowerk News) Cefic organised on June 23, 2011, its first Nano & REACH workshop to contribute to the timely debate on nanomaterials in the context of the REACH regulation. The workshop brought together close to 150 industry experts, policymakers and scientists and featured presentations by prominent experts in the field.
Nanomaterials are high on the agenda for industry and regulators alike. To fully leverage the societal benefits of these emerging technologies and materials - for example in the fields of energy and healthcare - they have to be effectively regulated, assessed and managed. Cefic's first Nano & REACH workshop focused on how REACH and its guidance apply to nanomaterials, together with some flavour on the latest developments around inventories and the OECD's work.
Opening the workshop, Lena Perenius, Cefic's Executive Director for Product Stewardship, reaffirmed industry's belief that the current EU regulatory framework is able to address nanomaterials, and REACH is an important piece of legislation in this respect. Evonik's Hans-Jürgen Wiegand, also chairman of Cefic's Nanomaterials Management Team, highlighted the big potential that nanomaterials represent for European industry. Jenny Holmqvist, Cefic's issue manager for nanomaterials, continued by presenting the current structure and processes put in place by Cefic to ensure a contribution from the chemical industry in the further development of the EU regulatory framework, international cooperation, safety research and stakeholder dialogue on nanomaterials.
"Communication remains a challenge", said Jenny Holmqvist, "Listening to stakeholder concerns and translating scientific arguments to different audiences is a key issue."
Hot topics on the EU agenda
From the authorities' side, representatives of the European Commission provided an update on the Commission's activities around nanomaterials and the preparation for the upcoming REACH review. Maila Puolamaa from DG Enterprise emphasised that the Commission's first regulatory review, published in 2009, found "no regulatory void" in terms of nanomaterials. The Commission is currently revising this conclusion in a second regulatory review, scheduled for the end of this year. The Commission is also preparing for the upcoming REACH review with a number of studies, some of them addressing the specific issues surrounding nanomaterials.
Left to right: Evonik's Hans-Jürgen Wiegand, chairman, Cefic Nanomaterials Management Team; Henrik Laursen, DG Environment; Otto Linher, DG Enterprise; and Bjorn Hansen, chair, OECD Working Party on Manufactured Nanomaterial
Left to right: Evonik's Hans-Jürgen Wiegand, chairman, Cefic Nanomaterials Management Team; Henrik Laursen, DG Environment; Otto Linher, DG Enterprise; and Bjorn Hansen, chair, OECD Working Party on Manufactured Nanomaterial.
Despite the lack of an agreed definition of a nanomaterial at EU level, Henrik Laursen, DG Environment presented the Commission's work on the issue so far, including the results of the public consultation back in November last year. He highlighted that the future definition has to be broad enough to be applicable to a wide range of sectors whilst not prejudging any potential legal implication of materials falling under the definition. He also discussed the measurement challenges associated with the task, saying the Commission recognised that further work is needed. The Commission's recommendation for the definition is expected to be published "during the summer".
Otto Linher from DG Enterprise continued the session by presenting ongoing European initiatives on nanomaterial inventories. The Commission doesn't have a position on whether there should be a harmonised inventory at the EU level, but is looking closely at the results of the work carried out by ECHA and the Joint Research Centre (JRC), as well as various projects initiated at the national level.
With regard to international cooperation, the European Commission's Bjorn Hansen, who also chairs the OECD's Working Party on Manufactured Nanomaterials, described how the OECD's work contributes to regulatory developments in the EU.
"There is a tidal wave of policy development on nanomaterials around the globe, and currently we are still ahead of this wave", Hansen said. "Contributing to the work of the OECD's Working Party for Manufactured Nanomaterials is a unique opportunity for industry to take a proactive approach in finding commonalities between industry and policymakers in a non-regulatory context."

He stressed that failing to do so will inevitably send the political message that no progress is possible, and strengthen the argument that more comprehensive legal requirements for nanomaterials are needed.

Implementing REACH for nanomaterials

The afternoon session focused on the three REACH Implementation Projects on Nanomaterials (RIP-oN) initiated by the European Commission to examine the applicability of existing guidance under REACH with regard to issues such as substance identity, information requirements, derived no-effect levels, exposure assessment and metrics.

Birgit Sokull-Klüttgen from the Joint Research Centre presented the first project (RIP-oN1) addressing substance identification. The report, published early June, is not conclusive but illustrates the views expressed in the project from industry, member states and NGOs. It will now be further discussed by the Member States competent authorities for REACH and CLP (CARACAL) before being sent to ECHA.

Cefic has recently commissioned an impact assessment to look into the implications of the options included in the report. Speaking from the industry perspective, Morris Cole from Cristal Global emphasised that existing guidance on substance ID and sameness are, in principle, well adapted also for nanomaterials. When properties differ between the nano-scale and the bulk form, these differences should be accounted for in information requirements, safety measures, and classification, labelling and packaging (CLP) requirements.

RIP-oN 2 and 3 evaluate the applicability of the existing guidance on information requirements (RIP-oN2) and exposure assessment and risk characterisation (RIP-oN3). Steve Hankin and Rob Aitken from the UK-based Institute of Occupational Medicine presented an overview of the ongoing projects. Even though the projects are not finalised yet, the preliminary conclusions by the project consortia show that the vast majority of the guidance documents are applicable to nanomaterials. Only minor changes to the existing guidance are proposed, such as some amendments around sample preparation, read-across, metrics and the inclusion of two new endpoints, surface area and shape. The final reports are expected to be published later in the summer.
Hans-Jürgen Wiegand concluded the day by saying that when organising the workshop, Cefic hoped there would have been more progress on some of the issues on the agenda, such as the EU definition for nanomaterials and the RIP-oN projects. However, he added that the slower than expected progress illustrates the complexities surrounding the debate on nanomaterials. This is proven time and again, both in the Commission's internal work and in industry discussions and debates between different stakeholders.
Source: Cefic
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