 |
A few key themes and
points came out during
the Dioxin 2002 week
in Barcelona.
These are listed below,
with more information
provided further down.
 |
Food and Feed I: Limit values for dioxins in feed and food have been in place since 1 July 2002.
Compliance monitoring will need to be undertaken.
|
 |
Food and Feed II: The EU representative in the plenary lecture on the first day of the
conference said that that the EU approach was to undertake screening combined with a
confirmatory method. As far as we know BDS' CALUX® technology is the only high
throughput screening technique that meets the required EU quality criteria.
COMMISSION DIRECTIVE 2002/70/EC spells out that "no evidence have yet been submitted of
commercially available kit-based bioassays having sufficient sensitivity and reliability
to be used for screening for the presence of dioxins at the required levels in samples
of foodstuffs and feedingstuffs".
|
 |
BDS' CALUX® initiatives: Inter-laboratory CALUX® validation in progress; Inter-laboratory
validation study for sediments complete (see literature).
|
 |
CALUX® highlights from Dioxin 2002
|
 |
BDS announces new CALUX® bioassays
|
Food and Feed
The European Union (EU) has set limit values (1 July 2002) for dioxins in food and feed products
in order to reduce dioxin exposure to EU citizens.
A series of maximum limits for dioxins in a variety of food and feed materials came into force
across Europe from 1 July 2002. The current limits will be reviewed and amended regularly to take
into account further materials and in order to set lower limits as "action" and "target" levels.
Target levels in food and feed would set the ultimate goal of achieving a human exposure below the
tolerable weekly intake of 14 programmes dioxins. Action levels would act as a tool of "early
warning" of higher than desirable levels of dioxin in food and feed, that would trigger
investigations to identify and reduce/eliminate the source of contamination.
For the latest EU information on the subject, see the
EU Lexicon website.
BDS' DR CALUX® initiatives: Inter-laboratory
Validation Studies for Food, Feed and Sediments
BDS has recently completed a detailed validation study for application of the DR
CALUX®
bioassay for analysing river and estuarine sediments for dioxins and dioxin-like compounds
on behalf of The Netherlands National Institute for Coastal and Marine Management ("RIKZ").
The report is published in the RIKZ
website, and an overview is available at our website at literature.
In the area of food and feed, BDS' DR CALUX® is the subject of the world's first truly
independent round-robin validation study for CALUX® technology. In this study, more than
20 laboratories are involved in testing and validating our CALUX® technology for food
and feed matrices. Co-ordination of the project is by
The Institute for Health and
Consumer Protection (IHCP) operating under the
Joint Research Centre (JRC)
of the EU located at Ispra in Italy. The results of this work will be published in due
course and intermediate milestones may also be reported.
Keep an eye on our website at www.biodetectionsystems.com for updates.
CALUX® Dioxin 2002 Highlights
| > |
The CALUX® assay had a higher profile at Dioxin 2002 than in previous years a trend
that seems set to continue. It is clear that one of the main drivers for this is the
setting of dioxins maximum limit values that apply across the EU already.
|
| > |
A number of inter-laboratory validation studies exclusively using BDS DR
CALUX® bioassay
have either been recently completed or are in progress.
|
| > |
DR CALUX® was used in one study as a tool for direct toxicity measurement and DR
CALUX®
has been used to determine relative potency values (REPs) for individual chemical substances.
BDS sees this as an ideal application of this type of technology. The clear benefits are the
avoidance of expensive and undesirable in-vivo work and the ability to test large numbers of
samples rapidly and cost-effectively.
|
| > |
A paper was presented on the use of a CALUX®-type reporter gene assay for quantitative
screening. CALUX® already gives quantitative data and can be used directly for decision-making.
In some country legal jurisdictions, data obtained by CALUX® operated within an accreditation
system is accepted directly by regulators. Further, CALUX® is used by some large globally
operating companies for direct company decision-making. In order to be used directly, the
desired degree of confidence must be obtained. BDS' DR CALUX® bioassay is already the only
bioassay that meets the required EU quality standards for a screening method. By extensive
implementation, experience of users, well designed inter-laboratory validation studies and
application of rigorous QA/QC standards, we know that BDS' DR CALUX® assay and its future
enhanced assays is more than sensitive and robust enough to become a stand-alone analytical
method for dioxins and dioxin-like compounds.
|
| > |
Finally, an enhanced dioxins responsive CALUX® cell line was presented by BDS, showing
improved sensitivity and selectivity. Even though current lines are sensitive enough for all
current applications, BDS is committed to the ongoing development of new bioassays with
improvement performance.
|
Illuminating Bioassays
On Monday 12 August 2002, at Dioxin 2002 in Barcelona, BioDetection Systems b.v. announced a
new series of CALUX® bioassays targeting a wide range of toxicological endpoints. The assays
have a broad range of applications both academically and practically.
The assays represent BDS' close end-pipeline and some are available today.
Contact us for details.
|
|