informed coatings markets on the safety
of its chemicals.
It will be a massive and complex task,
as was made clear at a workshop in
November on the issue at the headquarters in Helsinki, Finland, of the European
Chemicals Agency (ECHA), which is responsible for administering REACH.
“Full implementation (of the requirements for exposure scenarios) will take
time,” said Sophie Mathieu, an environment issue manager, at the meeting where
she spoke on behalf of the Downstream
Users of Chemicals Co-ordination Group
(DUCC), which represents the coatings
and other downstream sectors.
A major difficulty with the drawing-up of exposure scenarios for the coatings sector is that the safety data in
REACH registrations refers only to individual substances and not to mixtures
of two or more chemicals as in dispersions, pigment preparations and other
types of coatings formulations.
Although the REACH regulation
stresses that formulators must pass
on to downstream users information
about individual substances through
exposure scenarios it does not give
much detail about how this should be
done with mixtures.
The regulation merely states that with
substances on their own or in mixtures
recommended risk management or control measures “should systematically be
conveyed through supply chains to prevent adverse effects” on human health or
the environment.
“The legal text does not prescribe
how to transmit exposure scenario information for substances in mixtures,”
said Mathieu. It does not stipulate, for
example, whether the information should
be added as an annex to the SDS or integrated into the body of the text.
In a draft version of the REACH regulation there was a requirement for safety
assessment of preparations or mixtures.
But EU government representatives decided to delete it on the grounds that
scientific methodologies for assessing
combinations of chemicals were still under development.
Another source of confusion is that
REACH is not the only piece of EU
legislation demanding that safety information be disseminated down the
supply chain.
Eva Lechtenberg-Auffarth of the
hazardous substances management unit
of the German Federal Institute for
Occupational Safety and Health (BAuA),
pointed out that a professional coatings
applicator, for example, has also to take
precautions under occupational health
and safety (OSH), environmental and
product specific regulations. “REACH
applies without prejudice of (existing)
OSH and environmental legislation,” she
told the meeting.
She also highlighted the dangers
of inconsistent safety information being sent through to end-users mainly
because of lack of knowledge about
downstream working conditions.
Chemical producers cannot properly
assess the behaviour of their substances in ‘real’ mixtures because they do
not know what the other mixtures are
nor do they have detailed information
on how they are used.
Despite knowing about the performance of their mixtures and typical application methods, formulators are often
not aware of specific on-site conditions,
she said.
Another dilemma discussed at the
Helsinki meeting was the different information needs of different operators
in the chain. A coatings producer will,
for example, want detailed data about
substances and risk management measures from upstream dispersion suppliers. But an end-user will desire from a
coatings manufacturer concise, understandable and more risk management-focused information.
Anita Hillmer, a REACH specialist at the car manufacturer Volkswagen
AG, complained that extended SDSs are
already becoming too complex and too
long because of large quantities of superfluous information.
The European coatings sector,
through its Brussels-based trade association CEPE, has been working on a
more practical and simplified approach
to exposure scenarios.
Sets of standardized exposure scenarios with the focus on what amounts
to safe use in generic conditions were
an option, Thomas May of DuPont
Performance Coatings, Wuppertal,
Germany, and a CEPE representative,
told the workshop.
He gave as an example a car refinish bodyshop using 300 products from
multiple suppliers with users mixing up
to 10,000 color shades. “All products are
used under similar operational conditions
and users will probably not vary (them)
and the risk management measures from
product to product,”May said.
Jon Birger Aarnes of Jotun, Norway,
outlined a CEPE case study on a mixture exposure scenario for a protective
coating based on information on all
“critical” substances in the formulation. Critical substances are defined as
those “that determine the risk for one
or more adverse effects via one or more
exposure pathways,” such as dermal
contact or inhalation.
Such an exposure scenario can be used
for approximately 30 similar products,
Birger Aarnes said. Among its advantages was its user friendliness and that it
could be fitted on a single page in a SDS
while a disadvantage was that, since it
was based on dominant substances, the
whole mixture was not assessed.
ECHA is now working on a guid-
ance on exposure scenario information
for mixtures, based to a certain extent
on the discussions in the workshop.
Bridget Ginnity of the agency’s risk
management identification unit in-
dicated that the key guidelines in the
document would include the use as far
as possible of standardized methods
and that information could be commu-
nicated in “several ways.”
But she warned that exposure scenario
information would have to be updated as
new data relating to risk management
measures and hazards became available.
With research on the safety risks of
mixtures still at a relatively early stage,
the European coatings sector faces the
prospect of having to update continually information in exposure scenarios
in SDSs. It is hoping that this need for
regular revisions will be met through the
introduction of software enabling the job
to be done automatically. CW