Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”

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On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”

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On June 26, 2008, the European Trade Union Confederation (ETUC) passed a resolution on nanotechnologies and nanomaterials, which calls for the application of the precautionary principle. The resolution states that application of the precautionary principle is necessary to avoid “past mistakes [made] with putatively ‘miracle’ technologies and materials. According to ETUC, the number of workers coming into contact with nanomaterials will increase sharply as nanotechnologies are applied to difference industry sectors, including the chemical, pharmaceutical, and electronics industries. The ETUC urges the European Commission (EC) to amend the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation “so as to give better and wider coverage to all potentially manufacturable nanomaterials.” Because nanomaterials are manufactured or imported below the threshold of one tonne per year and may evade the REACH registration requirements, “ETUC demands that different thresholds and/or units (e.g., surface area per volume) are used for registration of nanomaterials under REACH.”

The resolution sets out a series of demands in different areas related to nanotechnology development:

• Marketing:

• REACH’s “no data, no market” principle must apply: nanometer forms of chemicals should not be allowed on the market unless sufficient data are supplied to show no harmful effect for human health and the environment;
• All nanomaterials, including those produced or imported in quantities below one tonne per year, must come within the REACH registration requirements; and
• A chemical safety report must be produced for all REACH-registered substances for which a nanometer scale use has been identified.

• Worker protection:

• Amend Chemical Agents Directive 98/24/EC to require employers to implement risk reduction measures for substances not proven to be harmless;
• Involve workers and their representatives in the assessment and reduction of nanomaterial-related risks;
• Improve worker information about nanomaterials that may be present in products to which they are exposed: safety data sheets must state whether nanomaterials are present; and
• Provide training and health surveillance for workers exposed to nanomaterials.

• Research and Development:

• Earmark at least 15 percent of public research budgets for health and environmental aspects; and
• Make health and safety at work aspects a compulsory part of all research projects.

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On August 30, 2007, Greenpeace International (Greenpeace) issued a report entitled Navigating REACH: An Activists’ Guide To Using and Improving the New EU Chemicals Legislation (Guide), which is intended to explain how the European Union’s (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation will work, what main issues are at stake, and how the law will be implemented. The Guide highlights provisions that non-governmental organizations (NGO) and citizens can use to promote safer chemicals and lead ultimately to better protection of human health and the environment from the adverse impact of hazardous chemicals. The Guide includes nanomaterials among the issues for NGOs:

• Adding nanomaterials to the scope of the legislation: The NGOs will keep working to highlight the need to improve current legislation to control the risks and manage this rapidly expanding industrial sector. According to the Guide, one of the windows of opportunity is the review of the scope of the legislation, as well as the review of information requirements for substances between one and ten tonnes (both in 2012). The Guide states that “this may be too late to start gathering data and limiting exposure to the rapidly increasing quantities of manufactured nanomaterials,” however.

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