Reflecting on REACH: Global Implications of the European Union's Chemicals Regulation
![handle is hein.journals/nantechlb4 and id is 383 raw text is: Reflecting on REACH:
Global Implications of the European Union's
Chemicals Regulation
DIANA BOWMAN* and GEERT VAN CALSTER**
ABSTRACT
The implementation of the European Union's comprehensive new regime for chemicals, as governed
by the Registration, Evaluation, and Authorisation of Chemicals (REACH') Regulation, signals a
fundamental shift in the way in which manufactured and imported chemical substances will be regulated
within the E. U. While REACH does not expressly refer to nanoscale substances, the wide scope of the
regime will ensure that nanoscale substances are captured under its provisions. This article presents a
brief overview of the new E. U. chemicals regime. It then evaluates the regulatory stance adopted by the
E. U. within the context of nanotechnology, including a shift in burden of proof regarding safety to
industry, the express inclusion of the precautionary principle within Article 1, and the use of mass as a
trigger for registration and testing procedures. The authors conclude with a discussion on the broader
and longer term impact of REACH on manufacturers and importers of nanoscale substances and
products containing nanoparticles, with particular reference to the implications of REACH beyond the
E. U.
I. INTRODUCTION
On December 18, 2006 the European Parliament and Council adopted the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (Regulation No
1907/2006), three years after intense negotiations began.1 The enactment of the regulation,
which entered into force on June 1, 2007,2 represents a significant milestone in the development
of the E.U.'s chemical regime. The broad regulatory framework of REACH has replaced forty individual
legislative instruments3 and signals a fundamental shift in the way in which manufactured and imported
* Diana Bowman is a research fellow in the Institute for Environmental and Energy Law at K.U. Leuven in
Belgium (di.bowman@law.kuleuven.be), and a research fellow in the Monash Centre for Regulatory Studies,
Monash University in Australia (Diana.Bowman@law.monash.edu.au).
** Geert van Calster is a professor of regulatory law at K.U. Leuven in Belgium (gavc@law.kuleuven.be,
www.law.kuleuven.be/imer), a visiting lecturer at Oxford University, and a Member of the Brussels Bar, Of Counsel
(practicing) with DLA Piper (geert.van.calster@dlapiper.com).
Press Release, European Commission, REACH: Commission Welcomes European Parliament Vote on New EU
Chemicals Legislation (Dec. 13, 2006) (IP/06/1799).
2 Commission Regulation 1907/2006, 2006 O.J. (L396/1), art. 141(1) [hereinafter REACH Regulation].
3 REACH Regulation, art. 139.
NANOTECHNOLOGY LAW & BUSINESS FALL 2007](ViewImageLocal?handle=hein.journals/nantechlb4&div=47&collection=journals&method=preview&ext=.png&size=3)
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Reflecting on REACH: Global Implications of the European Union's Chemicals Regulation
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