November 24, 2010 by Rhiannon Smith
Early in November, I attended a workshop on nanomaterials “The Regulation of Nanotechnologies under REACH” organized by Mayer Brown and the Nanotechnology Industries Association in London. Despite the tube strike, the workshop was worth attending, highlighting a number of issues regarding nanomaterials.
The workshop was attended by representatives from a range of environmental and industrial organisations, with backgrounds both inside and outside the nanotechnology sector. During the workshop, the discussions displayed a wealth of knowledge about nanomaterials and nanotechnologies in particular and REACH and European environmental legislation in general.
Run by Steffi Friedrichs and Jean-Philippe Montfort, the workshop included information on a range of issues, from the definition of nanomaterials, through the applicability of REACH to the legality of independent Member State initiatives. The workshop covered the main issues faced by nanomaterials submissions and the nanotechnology industry under REACH registration:
- The definition of nanomaterials;
- The provisions of REACH currently applicable to nanomaterials;
- Member State initiatives on nanomaterials;
- The Legality of national legislation in the context of REACH and the EC Treaty;
- RIP-oNs and other Commission initiatives on nanomaterials related to REACH;
- REACH Scope Review;
- Is compliance with REACH sufficient?
I’ve summarised my notes from the workshop into the following blogs: “Nanomaterials: definitions and registrations under REACH”, “Nanomaterial provision and compliance under REACH” and “National legislation of nanomaterials in the context of REACH”. Some general conclusions from the workshop are provided below.
Although a definition has not yet been agreed, the European Commission is expected to recommend that nanomaterials consist of more than 1% particles or internal or external structures with at least one dimension in the range of 1-100 nm or have a specific surface area by volume greater than 60 m2cm-3, excluding particles with a size less than 1 nm. As there are no direct provisions for nanomaterials under REACH, they may or may not be subject to a range of REACH requirements.
The Commission has stated that nanomaterials should be considered as substances, and as such nanomaterials should be reviewed by companies on a case-by-case basis to see which regulations are applicable. Where a separate EINECs number is not available nanomaterials should be considered the same substance as their bulk forms and therefore registered under a combined submission. The combined registrations may have implications for tonnage limits and test and risk assessment methodologies and raises questions regarding the extent to which forms with differing properties can be considered the same substance.
Outside of REACH regulations, some Member States have proposed national measures on nanomaterials. However, there are arguments that these would not be applicable as the 2012 REACH Scope Review is expected to address nanomaterials. REACH Implementation Plans on Nanomaterials, covering identification, information requirements and exposure assessment and hazard/risk characterisation, will provide advice to the Commission on the applicability of REACH to nanomaterials. However, the question of whether compliance with REACH is sufficient requires a review of several concepts and pieces of legislation.
Although nanomaterials must comply with the REACH regulations, REACH compliance may not be adequate to prevent liability or to ensure compliance with other obligations. The development risk defence, although not always applicable, means that nanotechnology companies must closely monitor and document advancements in scientific and technical knowledge in order to ensure compliance and limit liability risks.
Beyond REACH compliance and nanotechnology safety and liability, the consumer and public authorities’ perceptions of nanomaterial risks may be the hardest issue to overcome. For this reason, many organisations, both in nanotechnology and risk assessment, are supporting proposals for changes to the REACH regulations under the 2012 REACH Scope Review. Outside of Europe, it is expected that the development of nanotechnology would benefit from international convergence to at least a certain degree.
From our blog
August 14, 2017 by Becky Marks