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Posted: Feb 06, 2012
Nanomaterials "just out of REACH" of European regulations
(Nanowerk News) REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed" (pdf), a new report by the nonprofit Center for International Environmental Law (CIEL). Nanomaterials, tiny manmade particles with extraordinary properties, are a fast-growing component of cosmetics, clothing, consumer electronics, and other products.
According to CIEL's David Azoulay, author of the report, "Three years ago, the Commission declared that REACH theoretically covered nanomaterials; but they continue to enter the EU market with little or no information on their potential risks, violating REACH's 'no data, no market' principle. The problem is that the regulation contains legal gaps and shortcomings that render it completely ineffective for nanomaterials."
The study documents four key gaps for nanomaterials in the registration phase of REACH, an essential step that requires chemical manufacturers and importers to provide key health and safety information.
REACH does not define nanomaterials, and contains no nano-specific provisions;
Most nanomaterials evade registration until 2018, yet they can still enter the EU market;
REACH's schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
REACH test guidelines fail to consider the special properties of nanomaterials.
"Just Out of REACH" also explores possible remedies to close these loopholes. Some have suggested renegotiating REACH to add specific provisions on nanotechnology. But this is politically impossible and could invite further weakening of the current regulation. Others have suggested changes to the technical guidance, but the study shows that these so-called solutions fall short of bridging the existing legal gaps.
Rather than re-opening REACH, the report proposes developing a stand-alone regulation, carefully aligned with the chemical rules, but specifically tailored to nanomaterials. According to Azoulay, "REACH could prove a useful instrument to better understand and regulate nanomaterials, provided it is coupled with a nano 'patch' that closes these inherent loopholes." Such a regulation would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.
This solution should be flexible and allow for future adjustments as nanomaterials are better understood, without requiring additional changes to REACH. "Flexibility must be a critical characteristic of any effort to regulate nanomaterials," says Azoulay. "Our understanding is still very limited; it will evolve, and our legal responses must be ready to do so as well. A "nano-patch" for REACH would provide that added flexibility."
Founded in 1989, the Center for International Environmental Law (CIEL), www.ciel.org, uses the power of law to protect the environment, promote human rights and ensure a just and sustainable society. With offices in Washington, DC and Geneva, CIEL's staff of international attorneys and experts work in the areas of human rights and the environment, climate change, law and communities, chemicals, trade and the environment, international environmental governance, biodiversity and international financial institutions by providing legal counsel and advocacy, policy research and capacity building.