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SCIENCE:
RISK ASSESSMENT
Environmental risk assessment (ERA)
of substances is a key component of the European notification
process for new substances(1) and biocides(2), and is
the basis of decision-making on priority 'existing' substances(3).
Under the new REACH legislation, ERA will play
an increasingly important role, as assessments will be
developed for far more substances.
As well as these important roles in
regulatory compliance, risk assessment is an extremely
useful tool in product development. Performing an ERA
at an early stage, or indeed understanding of the properties
and factors which drive the outcome, are a very useful
input to inform the R&D process.
Standard
models and methods
Standard guidance exists for ERA of new and existing substances
and biocides(4), and more recently guidance for both human(5)
and veterinary medicines(6) has been published. At Envision
Chemistry, we are familiar and experienced with the various
techniques and models.
In the most basic terms, a risk assessment
is developed as follows:
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Releases to air and waste water associated
with production, processing, use and disposal are
estimated |
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Chemical properties determine the environmental
fate of released substance
This is quantified as Predicted Environmental Concentration
(PEC) |
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The Predicted No-Effect Concentration (PNEC) is
derived from effects seen in standard tests |
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If PEC/PNEC exceeds 1, the level of risk is unacceptable. |
Our experience shows that certain properties
(such as degradability) dominate the outcome, and that
the magnitude of releases is of vital importance. Hence
ERA can be extremely important to inform all stages of
product development, from lead development through to
product stewardship in the notification process. Such
an approach can allow companies to identify potential
lead substances, which are not likely to present a risk,
or to identify limits within which acceptable levels of
risk are maintained.
| 1 |
Commission Directive 93/67/EEC on Risk
Assessment for New Notified Substances |
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| 2 |
Directive 98/8/EC of the European Parliament and
of the Council concerning the placing of biocidal
products on the market |
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| 3 |
Commission regulation (EC) No 1488/94 on Risk Assessment
for Existing Substances |
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| 4 |
Technical Guidance Document on Risk Assessment.
European Commission Joint Research Centre, European
Communities 2003, downloadable from ECB website at
http://ecb.jrc.it/existing-chemicals |
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| 5 |
Note for Guidance on Environmental Risk Assessment
of Medicinal Products for Human Use, CPMP/SWP/4447/00
draft, European Agency for the Evaluation of Medicinal
Products, 24th July 2003 |
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| 6 |
Note for Guidance on Environmental Risk Assessment
for Veterinary Medicinal Products other than GMO-containing
and immunological products, EMEA/CVMP/055/96-FINAL,
European Agency for the Evaluation of Medicinal Products,
January 1997. |
Photography courtesy of Emanuel
Lobeck
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