Human health: risk assessment completed
Although not classified in the EU as a dangerous substance, in 1994 the European Commission Regulation 1179/94 listed Deca-BDE in the Priority List 1 and designated the UK government as the Member State rapporteur for the environmental assessment and the French government for the human health aspect.
After 10 years of scientific research and hundreds of studies conducted and/or reviewed, both the environment and human Risk Assessment reports concluded that there was no significant risk in these areas. On that basis, the EU Competent Authorities agreed on 26 May 2004 to finalise the Risk Assessment with no restrictions to the use of Deca-BDE beyond those already in place. Industry committed to initiate an independent biomonitoring program and a further neurotoxicity study, both of which are currently being conducted. The EU Competent Authorities also agreed during the same meeting that issues relating to the environmental findings of Deca-BDE in Europe should be addressed by the initiation of a voluntary industry monitoring programme. This is complemented by a further voluntary programme of industrial emissions control in partnership with Deca-BDE user industries in Europe, VECAP. An additional study on neurotoxicity was undertaken and finalised at the end of 2010.
Environment: risk assessment 100% completed
The European Commission Scientific Committee on Health and Environmental Risks (SCHER) adopted an Opinion in March 2005 on the Environmental Risk Assessment of Deca-BDE. The Opinion stated that the risk assessment had been “well done”. Both the European Commission and the UK government, which led the environmental risk assessment, have made clear that the SCHER opinion provided no new evidence demonstrating a risk from Deca-BDE, and that the calls made in the Opinion for risk reduction measures to address the low levels of Deca-BDE found in some environmental studies are already being addressed by the industry’s monitoring and emissions control programmes developed in conjunction with the EU authorities.
The EU Risk Assessment of Deca-BDE has been regularly updated since 2004 to take into account new science. Until now it has looked into over 1000 studies performed on Deca-BDE. On December 2007 the EU Member State Competent Authorities met to discuss the latest science available on Deca-BDE and the progress achieved by VECAP. The Committee confirmed the updated Risk Assessment report conclusions. They also agreed that the ongoing scientific and voluntary emission reduction programmes are progressing and committed to reviewing these programmes regularly under REACH.
On 28 May 2008, conclusions of the EU risk assessment for Deca-BDE were published in the Official Journal of the European Union. This Risk Assessment has been incorporated into the Registration under the EU REACH Regulation.
Deca-BDE was registered under the EU’s REACH Regulation in September 2010. The UK’s Advisory Committee on Hazardous Substances (ACHS) presented their conclusions following a review of emerging studies on Deca-BDE on 14 September 2010. The ACHS’s conclusions did not lead to any immediate change in the European regulatory status, including classification and labeling of Deca-BDE. The UK’s Department of Environment (DEFRA) and Environment Agency considered ACHS’s conclusions in consultation with other bodies on the UK Competent Authority for REACH and on 3 August 2012 submitted an Annex XV Dossier to ECHA proposing Deca-BDE as a substance of very high concern under REACH.
On 19 December 2012, Deca-BDE was included amongst 54 substances as SVHC in the EU's Candidate List (the list of substances that are candidates for Authorisation under REACH). Producers and importers of articles containing Deca-BDE in quantities totalling over one tonne per producer (or importer) per year and above a concentration of 0.1% weight by weight (w/w) will be subject to the duty to notify (Article 7) and duty to inform (Article 33) as per the standard requirements under REACH.
A consolidated Risk Assessment text has been published by the European Commission's Joint Research Centre.