EC Confirms That REACH Provides Best Framework for Nanomaterial Risk Management

The European Commission (EC) has concluded, in its second regulatory review on nanomaterials, that, while certain challenges continue to face those trying to assess their potential risks, the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) “sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures.” Still, the EC acknowledges that “more specific requirements for nanomaterials within the framework have proven necessary,” and thus it “envisages modification in some of the REACH Annexes and encourages ECHA [European Chemicals Agency] to further develop guidance for registrations after 2013.”

REACH took effect in June 2007. Viewed as the strictest law regulating
chemical substances to date, it requires all chemicals imported or produced
in the European Union (EU) over a certain quantity to be registered and the
manufacturers and importers to gather and report information about the
chemicals’ properties. The law’s provisions will be phased in over 11 years.

The EC review reports that 11 million tonnes of nanomaterials, with a market
value of about EUR 20 billion, are on the market globally. It further estimates
that 300,000 to 400,000 EU jobs are directly linked to nanotechnology. According to the EC, “limited data exist on manufactured nanoparticles in the
workplace and the environment” and “[d]etecting nanomaterials in complex
matrices such as cosmetics, food, waste, soil, water or sludge is even more
challenging.” Yet, the EC continues to maintain that “the risk assessment
paradigm used for the evaluation of standard food products is also appropriate
for nanomaterial applications in the food and feed chain.” It justifies
applying REACH requirements to nanomaterials given their flexibility, stating
“[m]any substances exist in different forms (solids, suspensions, powders,
nanomaterials, etc.). Under REACH, different forms can be considered within
a single registration of a substance. However, the registrant must ensure the
safety of all included forms and provide adequate information to address the
different forms in the registrations, including the chemical safety assessment
and its conclusions.”

Critics of the EC approach reportedly claimed that it was “dragging its feet”
on nanomaterials regulation. Swedish MEP Carl Schlyter, a spokesperson for
the Greens movement, said, “The Commission has dodged the key issue by
comparing nanomaterials with normal substances on the sole basis that not
all nanomaterials may be toxic.” He also claimed, “It is highly misleading to
suggest that the generic rules of REACH, designed for normal substances, are
appropriate for nanomaterials, and contradictory to the calls for a case-bycase
approach for the risk assessment of nanomaterials.” See Nanowerk News,
October 4, 2012.