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6 Risk Assessment and Management of Chemical Products
are often different from chemicals that occur naturally in the environment and
therefore likely to have increased potential to pose a risk to natural systems.
As a method, product risk assessment aims to avoid damage to humans and
the environment by characterizing and managing the hazardous properties of and
exposure to a chemical product. This chapter on product risk assessment focuses
on the toxic effects of a product. In the next chapter on process risk assessment
(Chap. 7), risks posed by physicochemical effects are investigated, which are
connected with hazardous properties relating to the release of chemical energy (such
as fire and explosion).
In view of the multiple hazards that can arise from a new chemical product,
prospective product risk assessment aims to prevent, both predictively and systematically, the use of a chemical product that causes harm to humans and/or
the environment. The goal here is to integrate the safety of a product into its
development, also in early design stages.
Product safety comprises (1) knowledge of the relevant product properties that
pose a hazard to humans or the environment and (2) knowledge of the measures
necessary for safe application, use, and disposal. Furthermore, it deals with two
main groups of products: technical products that are used within industry and
handled by industry employees and consumer products that are used within the
household and handled by consumers. Chemicals within both groups of products can
also enter the environment, meaning that both human health risks and environmental
risks need to be assessed.
In contrast to the more general definition of risk that considers the probability of
occurrence and extent of damage, the concept of risk assessment involved here does
not always explicitly consider probability. Instead, both the description of exposures
and the resulting effects are often deterministic. However, existing uncertainties
can still be considered by including confidence factors, and some probabilistic risk
assessment methods exist and will be introduced.
In addition to the many benefits that it provides when applied voluntarily, the
need for product risk assessment also originates from clear regulatory requirements.
In the EU (and in many other regions), a new chemical product must be declared to
and registered with the appropriate authority before it can be marketed (see Chap. 3).
The time required for this registration often determines the time to market—a time
that today more than ever is a key factor for the competitiveness and market success
of a new product.
In this chapter, the concept of product risk assessment as well as its associated
opportunities and limitations is presented and discussed. The information provided
here refers to a framework that is largely based on EU legislation and focuses on the
development of new chemical products. A case study example using cotton dyeing
is provided to illustrate the steps within a product risk assessment. Further, detailed
information and illustrative examples of applying risk assessment of chemical
products can be found in van Leeuwen and Vermeire (2007) and ECHA (2018).
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