Date: 2002-08-01Source: BioDetection SystemsLink: http://www.dioxin2002.com/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.
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