Europe
They describe how people and the
environment may be exposed to a hazardous chemical or substance during
its entire life cycle – from its use in the
manufacture of a coating or other product, its application and disposal. More
importantly, the scenarios recommend
how exposure to the substance should be
controlled to ensure its safe use.
The big challenge for coatings companies and distributors is that their
products can comprise more than 20 different chemicals each of which has its own
REACH safety profile and exposure scenario. Under the legislation the coatings
producer or distributor has the responsibility of providing a exposure scenario
covering the chemicals in a single product.
For exporters of chemicals, coatings
and other formulated products, the exposure scenario requirement reinforces
a widely held view outside Europe that
REACH is a barrier to trade. The Society
of Chemical Manufacturers and Affiliates
(SOCMA), representing U.S. speciality chemical producers, reckons that
REACH compliance is equivalent to a
tariff of more than 20 percent.
To help sort out the problems with
exposure scenarios, ECHA has set up
a task force of regulators and industry
representatives – the Expert Network
on Exposure Scenarios (ENES). It is in
the process of deciding how the risks of
mixtures or formulations containing hazardous chemicals should be assessed. It
also investigating how the content of exposure scenarios, particularly the advice
on how to manage risks, should be best
communicated down the supply chain
through extensions to a product’s Safety
Data Sheet (SDS).
A major difficulty dealing with the
risks from mixtures in coatings and other
products is that toxicologists and other
experts still cannot agree how to measure
the dangers from chemicals in mixtures.
“We have been identifying (in ENES)
at least 15 methods for evaluating mixtures but there are clearly others as
well,” said Erwin Annys, REACH and
chemicals policy director at the European
Chemistry Industry Council (Cefic), representing chemical, including formulation, producers.
Another complication with exposure
scenarios is the information on uses has
to be passed upstream to the chemical
and formulation producers for conversion into exposure scenarios.
Scenarios for individual chemicals
are drawn up by producers or importers both to be included in their REACH
registration dossiers and to passed on
to formulators. But those for mixtures
are put together by coatings companies
and distributors or other suppliers of
formulated products mainly by relying on the information in the exposure
scenarios provided by the suppliers of
individual chemicals.
Critics of the exposure scenario
concept claim that, due to the remoteness of chemical manufacturers and
even formulators from end-users, information in scenarios on the risks of
individual chemicals is likely to be inconsistent with specific working conditions and processes.
The numbers of uses and processes
covered in a typical exposure scenario
could extend into double figures. They
include details of indoor and outdoor
conditions, modes of application, types
of packaging and delivery, mixing
equipment, substance concentrations
and task durations. In addition the
scenarios list recommended rick management or control measures, such as
ventilation equipment and protection
clothing and accessories.
To ensure that exposure scenarios
are kept short and easy to understand, a
system of generic exposure scenarios has
been developed so that the scenarios can
be drawn up by sector trade associations
for distribution to the majority of their
members. This is a strategy which is being adopted by the European Council of
Paints, Printing Inks and Artists Colours
Industry (Cepe)—the main European
coatings trade association.
“We believe that generic exposure
scenarios will cover around 80 percent
of normal uses of coatings and printing
inks,” said Janice Robinson, Cepe’s direc-
tor of product relations. “Providing ex-
posure scenarios which apply to specific
uses other than generic ones would be
outside our responsibility.”
Within a consortium of formula-
tor sectors—the Downstream Users
of Chemicals Co-ordination Group
(DUCC), which in addition to coatings
companies embraces manufacturers of
detergents, adhesives, crop protection
products and construction chemicals –
Cepe is working on the harmonization
of information from chemical producers.
This should help to prevent different ex-
posure scenarios being provided for the
same individual chemical.
“With the help of consistency in
the information on substances, we can
then ensure that the generic exposure
scenarios match the risk data provided
by the suppliers of hazardous chemicals,” said Robinson.
The big task facing DUCC and other
individual or consortia organizations is
the development of relatively uniform
methods for assessing risks from chemical mixtures. One key question is how
inclusive the mixtures exposure scenarios
should be.
“For mixtures there is no legal obligation to provide complete exposure
scenarios of all substances but (this is)
information which may be needed by
some companies,” explained Ophelie
Roblot, health, safety and environment
director of the European Association of
Chemical Distributors (FECC), at a recent ENES meeting.
Currently members of ENES are concentrating on developing an assessment
system which would focus on gauging the
impact of potentially the most hazardous
substances within mixtures.
“Our intention is to find the overlaps between the different methods and
to try to combine them in an approach
which covers all the aspects of mixtures
evaluation as much as possible so that
it can be used virtually for every mixture,” said Annys.
The toxicology of mixtures, however, is a relatively young science with
issues like the reactivity of some hazardous chemicals within them still unclear. Coatings formulators are likely
to be still updating and refining the exposure scenarios of their products well
beyond 2018 when the implementation
of REACH is due to be completed. CW