Coming Soon:
DNELs
How will REACH-mandated exposure
limits affect IHs and labs?
BY JOE UNANGST
Adopted in December 2006, the European Union’s Reg- istration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation is the strictest law ever enacted on chemical manufacturing. REACH was de- signed to systematically identify the hazards and risks
of chemicals, allowing for appropriate risk management
measures by industry and, if necessary, providing for
further regulatory action.
REACH requires EU manufacturers and importers to register
substances they produce or import in quantities over 1 tonne per
year. The registration requirement applies to substances on their
own, in preparations, and in articles if they are intentionally released into commerce. Timing and other factors affect the required
registration date; some manufacturers needed to comply as early
as June 1, 2008, while others have until June 1, 2018.
The next major registration deadline is fast approaching. By
Dec. 1, 2010, the EU will require companies to register substances
that will be manufactured or imported according to the following
criteria:
• In quantities of 1,000 or more tonnes per year
• In quantities reaching 1 tonne or more per year for substances
classified as carcinogenic, mutagenic or toxic to reproduction
(International Association for Research on Cancer Category 1
or 2)
• In quantities reaching 100 tonnes or more per year for sub-
stances classified as very toxic to aquatic organisms and
which may cause long-term adverse effects in the aquatic
environment
In addition, manufacturers and importers of chemicals that
meet these criteria are required to calculate a new exposure
limit, known as a Derived No-Effect Level (DNEL), as part of
their chemical safety assessments for these substances. The
publication of DNELs starting Dec. 1 may have far-reaching
consequences for industrial hygienists, analytical laboratories,
and other OEHS professionals.
