The
Boundaries
of REACH
Operational Conditions and
Risk Management Measures
Define the Obligations of
Downstream Users
BY ROBERT SKOGLUND, ROBERT ROY, PERRY LOGAN, AND JOCELYN WALTON
REACH (Registration, Evaluation, Author- ization and restriction of CHemical sub- stances), the European Union’s
regulation on chemicals and their safe use, is
fundamentally changing the way environmental
and occupational hygiene is practiced. REACH
impacts any company that puts products into the
EU market, but especially impacts those that
have manufacturing facilities in the region.
The parties responsible for putting REACH-regulated
substances into European markets must, when certain criteria are met, develop quantitative hazard and exposure
estimates and document, using a risk assessment, that the
substances are safe for their registered uses. This information must be documented in a chemical safety report
(CSR) and communicated to downstream users via exposure scenarios (ESs) as part of the extended safety data
sheet (eSDS). REACH obligates downstream users subject
to the regulation to follow the operational conditions
(OCs) and risk management measures (RMMs) that are detailed in the ES. In aggregate, the OCs and RMMs define
the conditions of use under which the substance can be
safely used.
While the practicing industrial hygienist has an important role in the development of ESs, CSRs and eSDSs,
this article focuses on their role in the downstream implementation of the conditions of use specified in the ES
by the manufacturer or importer.
Exposure Scenario
In the context of REACH, an exposure scenario is a set
of conditions that describes how a substance may be
used so that the potential human exposure and environmental release are controlled to below acceptable limits.
The use is therefore determined to be “safe.” These conditions include both the OCs and RMMs.
OCs are the parameters that prevail during manufacture or use that might have an impact on exposure or
release. These parameters include the physical form of
the substance and process details such as amount, duration, frequency of use, and workplace dimensions.
REACH guidance loosely defines a minimum set of OCs
that should be included in every scenario. RMMs also
impact exposure or release, but, in contrast to OCs, are
purposely introduced during manufacture or use. RMMs
primarily include engineering controls and personal protective equipment. Depending on the situation, a specific
parameter can be either an OC or an RMM.
The requirements for an ES are spelled out in Section 5 of
Annex I of the REACH regulation (EC 1907/2006) and focus
on the OCs and RMMs. Additional details on the ES are
found in the expansive set of guidance on information requirements and chemical safety assessment available on the
European Chemical Agency’s (ECHA) website (
http://echa.eu-ropa.eu/). An ES should describe the uses and activities it
covers (title sections), provide information on calculated
