measurement, or both, that an equivalent
or higher level of protection is being provided. This decision should be sufficiently
documented. Note, too, that when exposure measurements are used to support a
decision under REACH, the data set is expected to be representative and robust.
Multiple ESs, Single Workplace
Compliance with a single ES can be complicated. But very few, if any, manufacturing processes include only one substance.
If a manufacturing process includes two
REACH substances, the intended use will
have to be sufficiently similar to two independently registered uses.
Let’s assume that the two sets of OCs
are sufficiently similar. It is still possible
that some RMMs are redundant, incompatible, or even contradictory, requiring
the downstream user to determine
whether a subset of the RMMs reasonably
fits within the boundaries of the two ESs.
If not, the user will need to either ask one
or both manufacturers or importers to
modify its ES or complete their own
chemical safety assessment. Since the
possibility of redundant, incompatible or
contradictory RMMs increases with each
additional ES, REACH compliance will
take considerable effort for complicated
manufacturing processes that need to
comply with multiple ESs. And because
of the staggered implementation of
REACH, new eSDSs will continue to be
made available for preregistered substances through 2018, and continuously
for new substances and substances that
cross new tonnage thresholds. This increases the likelihood that, after having
conducted an assessment to meet one
vendor’s RMMs, a downstream user could
receive a new eSDS with additional ESs,
requiring a reassessment.
Coexistence of DNELs and OELs
DNELs (derived no effect levels) and
OELs are quantitative estimates of “safe”
levels for human exposure and are derived by applying safety factors to a no
observable adverse effect level (NOAEL),
a lowest observable adverse effect level
(LOAEL), or another toxicological point
of departure. However, the intended purpose of an OEL is to establish the acceptable limit of exposure in a workplace,
while that of a DNEL is to establish the
OCs and RMMs that define the safe use
of a substance within a specific ES. As a
result, the obligation of downstream
users, under the EU Chemicals Directive,
is to maintain exposures below the OEL.
Under REACH, the obligation for the
downstream user is to implement the
OCs and RMMs specified by the manufacturer or importer.
The mandatory inclusion of both the
applicable DNELs and the national OELs
(for the EU member state in which the
safety data sheet is being provided) in
section 8.1 of the new EU eSDS may well
cause confusion. When both a DNEL and
a national OEL are provided for a substance, the OCs and RMMs must be implemented, but exposures must be
controlled to below the national OEL.
When no national OEL exists and only a
DNEL is provided, the OCs and RMMs
must be implemented. It is good practice
to monitor the resulting exposures, but
the DNEL is not the default limit for exposure control. When other, non-national
OELs, such as the ACGIH® TLVs® or
AIHA® WEELs, differ from the DNELs, IHs
should consider whether these consensus
limits are more robust than the limits set
by the manufacturer or importer. Of particular concern are DNELs from multiple
sources that can vary significantly from
one another. If there are no national or
consensus OELs, the DNELs may be a reasonable default limit for control, but IHs
should understand their intended uses,
limitations, and how they were derived.
As mentioned earlier, downstream
users may deviate from the OC and RMM
recommendations of the manufacturer or
importer. In this case, users must develop
their own ESs and demonstrate, by either
modeling or a robust set of sampling
data, that the anticipated exposure associated with the alternative OCs and
RMMs is less than the DNEL. However,
the role of the DNEL ends with the finalization of the ES. If there is a national
OEL for the substance, the workplace
limit will be the OEL and not the DNEL.
DNELs are not intended to be, or re-
place, OELs. Rather, they are part of the
REACH assessment process designed to
establish OCs and RMMs. They also con-
veniently fill a gap that exists due to the
insufficient number of national and con-
sensus OELs. However, DNELs are devel-
oped by the manufacturer or importer,
and therefore may not have the scientific
rigor or broad peer review of national
and consensus OELs. The coexistence of
DNELs and OELs in a workplace will not
always be straightforward, so training on
this topic should be provided to all af-
Under REACH, the OCs and RMMs specified by the manufacturer or importer set
a boundary around how a safe working
environment can be established and
maintained. These specifications can
provide much-needed assistance to
small- or medium-size enterprises that
lack dedicated occupational health and
safety resources. However, unless managed carefully, they can also limit a robust occupational health and safety
program’s ability to maintain a safe
working environment in a responsive
and cost effective manner.
To be effective members of a REACH
compliance team, IHs must develop three
skill sets. First, they must cultivate a thorough understanding and a functional expertise with obligations of REACH, the
concept of an ES, and the details of OCs
and RMMs. Second, they must add exposure assessment skills to their repertoire,
including an understanding of both sam-pling/analytical and modeling techniques.
And finally, they must foster the art and
science of deciphering OCs and RMMs
and developing exposure control strategies that fit within their boundaries.
Robert Skoglund, PhD, DABT, CIH, is the senior laboratory manager for the Material EHS section of the
3M Corporate Medical Department and is a member
of the leadership team responsible for REACH compliance.
Robert Roy, PhD, DABT is a lead toxicology specialist in the Toxicology Assessment and Compliance
Assurance section of the 3M Corporate Medical Department and is responsible leading the development of 3M Exposure Guidelines and REACH
DNELs. Dr. Roy is also a member of the AIHA WEEL
Jocelyn Walton, MPH is a senior industrial hygienist
in the Material EHS section of the 3M Corporate
Medical Department and is involved in the development of CSRs, ESs, and eSDSs.
Perry Logan, PhD, CIH is the technical manager for
the Industrial Hygiene section for 3M EHS Operations and leads the implementation of OCs and
RMMs in 3M facilities in the European Union. Dr.
Logan is currently President-Elect for the Academy
of Industrial Hygiene, which promotes advancements to the professional practice of IH globally.
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