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The European Chemicals Agency Board of Appeal ruled March 2 that chemical companies operating in the EU are not required to provide specific information about the nanoscale forms of their substances.
The Board of Appeal annulled a 2014 European Chemicals Agency decision that required a group of companies to provide more information in their REACH registration dossiers about the substance identity of nanoforms of titanium dioxide, which is used in applications such as paints and adhesives.
The Board of Appeal said REACH (Regulation No. 1907/2006 on the registration, evaluation and authorization of chemicals) does not require companies to provide in their registration dossiers nanospecific substance identity information separately from substance identity information relating to the bulk form of the substance. The chemicals agency exceeded its powers by asking for nanospecific information, the board said.
Under REACH, “a registrant is at liberty to give a broad definition of the substance” that would cover bulk and nano forms, the Board of Appeal decision said.
The ruling could put pressure on the European Commission to clarify what information companies should provide about nanosubstances.
The “literal language” of REACH does not require companies to submit specific nanoform substance identity information, and the European Chemicals Agency “will not be able until the legislation is revised to ask for that information,” Herb Estreicher, a partner with Keller and Heckman LLP in Washington, D.C., told Bloomberg BNA March 2.
In the U.S., the Environmental Protection Agency notes that “chemical substances that have structures with dimensions at the nanoscale—approximately 1-100 nanometers (nm)—are commonly referred to as nanoscale materials or nanoscale substances. A human hair is approximately 80,000 to 100,000 nanometers wide.
“These chemical substances may have properties different than the same chemical substances with structures at a larger scale, such as greater strength, lighter weight, and greater chemical reactivity.
“These enhanced or different properties give nanoscale materials a range of potentially beneficial public and commercial applications; however, the same special properties may cause some of these chemical substances to behave differently than conventional chemicals under specific conditions,” the EPA says.
The European Chemicals Agency has said previously that nanosubstances were underreported in REACH registration dossiers, and has pushed for clarification of the information it can ask from REACH registrants on nanosubstances.
The European Commission, the EU’s executive arm, carried out a consultation in 2013 on how the REACH annexes should be modified to better specify information requirements related to nanosubstances. The commission has said a number of times since then that a proposal to amend the annexes would be published, but no proposal has emerged.
David Carlander of the Nanotechnology Industries Association told Bloomberg BNA the Board of Appeal decision showed that regulators and companies were “still working on how to correctly manage and work with REACH.”
The decision may put additional pressure on the European Commission to propose the modification of the REACH annexes, Carlander said.
Estreicher said: “It may well be that this decision intensifies calls” for the REACH annexes to be adapted to account for nanosubstances.”
Estreicher added that although the Board of Appeal decision clarified that ECHA could not ask for nanospecific information related to substance identity, the agency could in principle ask companies to provide information on the environmental and health risks of substance nanoforms.
However, there is currently little evidence that the nanoforms of substances present different environmental and health concerns to the bulk forms of substances and consequently, the chemicals agency could be “hard pressed” to justify such nanospecific information requests, Estreicher said.
The agency told Bloomberg BNA March 2 that the Board of Appeal had made a “literal reading” of REACH and had ruled that the agency “has no competence to request substance identity related information on nanomaterials.”
The agency said it would “assess the reasons set out by the Board in its decision and consider its impact on the regulatory strategy for nanomaterials.”
“Nanomaterials require attention by authorities and generally a better understanding of the intrinsic properties of such materials is needed,” the agency added.
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The European Chemicals Agency Board of Appeal decision on information on substance nanoforms is available at http://bit.ly/2mQ8byy.
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