EBFRIPEUROPEAN BROMINATED FLAME RETARDANT
INDUSTRY PANELA SECTOR GROUP OF

www.ebfrip.org

16 May 2006

Deca-BDE – Summary status report on additional information
requirements
Environmental monitoring programme
Scope
At the 26 May 2004 Competent Authorities meeting, it was agreed that there should be astudy “monitoring the environment to establish the trends in levels of contamination forboth the substance and its more toxic and bio-accumulative degradation products over a
suitable period of time”.
A 10-year environmental monitoring programme of Deca-BDE is being carried out, afterconsultation with the rapporteur. It involves monitoring sediment in the UK, theNetherlands, Germany, France and Ireland and sludge in the UK and the Netherlands.
Bird eggs are to be monitored in the UK and the Norwegian Arctic. These results willallow establishing trends over time on the presence of Deca-BDE in the environment.
In addition, at the request of the rapporteur, a pilot study on monitoring air samples in theUK was carried out to investigate the feasibility of reliably monitoring Deca-BDE in air.
Status
The environmental monitoring programme was started in April 2005. The first samplinground was completed in the fourth quarter of 2005 by the institutes involved in theprogram (Vrije Universiteit Amsterdam - IVM, the UK Centre for Environment, Fisheries
and Aquaculture Sciences – CEFAS, the UK Centre for Ecology and Hydrology – CEH,
and the Norwegian Polar Institute) and the laboratories are analyzing the samples. An
update report has been provided to the UK rapporteur in early May and a full first interim
report on the environmental monitoring results will be sent to the UK rapporteur by theend of May 2006. This will be the first of the bi-annual reports planned in the frameworkof the 10-year environmental monitoring programme of Deca-BDE aimed at establishinga temporal trend of levels of Deca-BDE in the environment.
It should be noted that after consultation with the rapporteur, the analysis of specific“marker congeners” was added to the scope of the programme. The amended protocol forthis programme was circulated to the TC-NES in December 2005. This will allow
specifically to analyse for the potential degradation of Deca-BDE to lower BDE
congeners. From past studies, there has been no correlation between findings ofbreakdown products in laboratories and findings in the environment.

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As a final point, it should be noted that the scientist leading the program, Prof. Jacob deBoer, and his research team have changed laboratories. Since 1 May 2006 the programme
has moved to the Vrije Universiteit Amsterdam (IVM), from The Netherlands Institutefor Fisheries Research (RIVO) in IJmuiden. This change will not impact the program
since it is only a change in location for the original team. The other laboratories involvedin the project since its initiation remain the same. While this change will have no
substantial impact on the project, due to relocation and the practicalities involved (settingup instruments, transfer of contracts, etc.) a minor delay of a few weeks was incurred.
The same considerations also apply to the analytical part of the biomonitoring
programme described below, which is also carried out by IVM.
The pilot study on air monitoring was completed in February 2006 and the final reportand results were communicated on 10 March 2006 to the UK rapporteur. The study
showed a high variation of the levels found (the range was between 5 and 45 pg/m3) witha standard deviation of 69%. Industry and the research laboratory (University ofLancaster) met on 21 February to discuss these results, in particular how the variation ofdata could be reduced, and investigate the need for further steps. The researchers arecurrently preparing a revised proposal aimed at reducing this variability.
Bio-monitoring programme
Scope
At the 26 May 2004 Competent Authorities meeting, it was agreed that it would benecessary to initiate “a suitable human bio-monitoring programme, including breast milk,
and the need for a trend analysis over a certain time period”.
A 10-year bio-monitoring programme has been started by industry to monitor Deca-BDE
levels in the blood of the European population. In a first phase, a pilot study will monitor
blood levels in 4 different European countries – the Netherlands, Norway, the UK andSpain - to find out if there are regional differences in the levels found. Based on the dataobtained in this pilot study, one country will be selected for further long-term monitoringof levels of DecaBDE over the full 10 year period.
StatusAfter the approval by the TC-NES meeting in November 2005 of the scope and protocol,
the 10-year blood bio-monitoring programme started in December 2005. The researchlaboratories involved in the programme are the Institute for Risk Assessment Sciences(IRAS), Utrecht, the Vrije Universiteit Amsterdam (IVM), both in The Netherlands andthe Norwegian Institute of Public Health. As requested by the Member States expert
group that agreed on the study protocol and scope, a method development-study iscurrently being carried out to verify the analytical methods, carry out an interlaboratorycomparison and to determine the most appropriate blood fractions to sample. The resultsof the pre-study are scheduled to be reported in June 2006. Such a biomonitoring
programme as requested needs the approval of the relevant national Medical Ethical2

Committees. The applications to the Medical Ethical Committees in the 4 countries havebeen filed in January 2006 in the four countries selected for the study and are currently
being processed. Approval is expected in May/June 2006. On that basis, a first interim
report is expected to be presented end-May 2007.
As already discussed in the environmental monitoring section, due to the move from Profde Boer from RIVO to IVM a slight delay in the analytical work occurred. The results ofthe pre-study may therefore be delayed by a few weeks.
Following consultation and discussion the Member States expert group has agreed with
the industry proposal to include Deca-BDE in the World Health Organisation (WHO)programme on breast milk monitoring in the framework of the WHO International
Program on Chemical Safety. This WHO program is a standard working program with awell established protocol already agreed by the participating countries and which has
been running since 1987. The WHO study has already been initiated (calls for interest
have been sent to Member States, etc.) and is due to be started in 2006.
Developmental neurotoxicity study
Scope
The 26 May 2004 Competent Authorities’ minutes defined one of the “outstandingquestions” needed to be addressed as “neurotoxic effects and uptake of the substance bymammals in laboratory studies”. To this end, it was agreed that there should be initiated“a further developmental neurotoxicity study in mice”.
StatusIn 2005, several meetings took place with the rapporteur as well as discussions with theEU expert group in order to define the most appropriate testing protocol for this study. It
has been difficult to reach an agreement on the scope and details of the study given thediffering views among the members of the EU expert group and the non-standard study
design they have requested. It took significant time and effort to identify a competentlaboratory able to lead the study. Moreover, since none of the contract researchorganizations (CROs) has experience with the non-standard dosing vehicle requested by
the EU experts (there are no historical control data on this vehicle), the laboratory insisted
to carry out a pre-study establishing important parameters that are crucial for carrying out
the definitive study.
A general agreement has been reached in the TC-NES meeting in March 2006 on thescope and outline of the study and on 31 March the rapporteur was informed about thedetailed study plan. In April 2006, a laboratory has been contracted to carry out the study.
There are remaining technical questions, including the decision on how to best pre-dosethe animals in the first part of the study, which are currently being addressed together
with the rapporteur. However, this has not prevented the initiation of the study since inthe first phase of the study the CRO is currently preparing a final, detailed, study protocol
and any comments received in the coming weeks can still be integrated. On the basis of
the general agreement reached on the general scope of the study, the study has officially3started at the end of April 2006 with results due in 2008. The experimental works arescheduled to start in late May 2006.
Conclusion
The different programmes covering the additional information requirements as agreed
jointly with the EU Competent Authorities in May 2004 are all progressing. The
developmental neurotoxicity study has been subject to a wide range of detailed technicaldiscussions with the rapporteur and Member State experts so as to reach agreement on thetesting protocol and scope for the study, which is now up and running. Both theenvironmental monitoring and the bio-monitoring programmes have been initiated, areproceeding according to schedule and will produce their initial interim reports for review
by the rapporteurs and TC-NES as previously agreed.

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