BSEF - EU Risk Assessments of BFRs

In May 2004 the EU Competent Authorities officially closed the scientific assessment of decabromodiphenyl ether (DecaBDE) with no restrictions due to the lack of risks identified for the use of this substance. This chemical is used as a flame retardant in textile backcoating in furniture in some EU countries such as Ireland and the UK to comply with more stringent fire safety requirements than exist elsewhere in Europe, and in the housings of computers as well as in other electrical and electronic applications.

Although not being classified in the EU as a dangerous substance, in 1994 the European Commission Regulation 1179/94 listed DecaBDE 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, both the environment and human risk assessment reports concluded that there is no significant risk on these areas. On that basis, the EU Competent Authorities agreed on 26 May 2004 to finalise the risk assessment with no restrictions in the use of Deca-BDE. In upcoming months industry will develop, with the French authorities, an independent biomonitoring program and, in relation to this program, a neurotoxicity study since a previous study had been declared invalid for risk assessment purposes. 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 will be complemented by a further voluntary programme of industrial emissions control in partnership with Deca-BDE user industries in Europe.

The first set of Codes of Practices for the use of Deca-BDE by both the plastics and the textiles industry were developed in the United Kingdom in September 2004. In the near future similar Codes of Practices will be developed, in cooperation with user industries, in other EU Member States such as Belgium, France, Italy, Germany etc.

Click here for the brochure “Voluntary emissions control action programme – Greening the textiles supply chain” .

The monitoring and emissions control programmes provide an unprecedented level of environmental & health protection for a chemical whose comprehensive risk assessment has not identified a risk. The details of these programmes will also involve close consultation with EU Member State technical experts.

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.

On 16 June 2005 the EU Competent Authorities noted progress on all the programmes. It was also decided that a format for industry to report progress on the emissions reduction programme to future Competent Authority meetings will be developed by the European Commission and the UK.

A consolidated risk assessment text is expected to be published shortly by the European Chemicals Bureau.

DecaBDE is the flame retardant with the most scientific data proving its compatibility in terms of human health, low and manageable risks for the environment and its tremendous contribution to society in terms of fire safety.

DecaBDE Risk Assessment conclusions were published in the Official Journal on 29 May. Please click here to access the document:

The EU finalised the risk assessment of octabromodiphenyl ether (OctaBDE) in 2002. This chemical is mainly used as a flame retardant in plastics for electrical and electronic equipment and in comparison to DecaBDE, is very much a minor flame retardant.

Although not being classified in the EU as a dangerous substance, in 1994 the European Commission Regulation 1179/94 listed OctaBDE 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.

The risk assessment identified no risks to the aquatic, terrestrial or atmospheric environments. The environment risk assessment stated also a need for further information and/or testing on the potential risks of secondary poisoning and of degradation. As regards human health, the risk assessment concluded that there is no risk through direct exposure to OctaBDE in consumer products. The human health risk assessment requested nevertheless further information and/or testing regarding concerns about impacts of repeated worker dermal and inhalation exposure and about indirect exposure via the environment.

The Risk Assessment of OctaBDE indicated to Member States to consider risk reduction measures as it considered that there was a high level of uncertainty associated to the potential risks identified in comparison to the level of information available at that stage. The Member States decision was formalised by the publication of a EU Commission Recommendation on the results of the OctaBDE risk assessment and in view of the Risk Reduction Strategy presented by the United Kingdom. The Commission Recommendation requested marketing and use restrictions for OctaBDE.

The EU finalised the risk assessment of diphenyl ether, pentabromo derivative (PentaBDE) in 2000.

In 2000 the European Commission Regulation 2268/95 listed PentaBDE in the Priority List 2 and designated the United Kingdom government as the Member State rapporteur for the risk assessment.

The risk assessment identified no risks to the aquatic, terrestrial or atmospheric environments. The environment risk assessment stated also a need for further information and/or testing on the potential risks of secondary poisoning resulting for biaccumulation. As regards human health, the risk assessment concluded that there were no risks through direct exposure to PentaBDE in consumer products. The human health risk assessment requested nevertheless further information and/or testing regarding occupational exposure and potential presence of traces of this substance in human breast milk.

The uncertainties arising from the conclusions of the risk assessment, in particular concerning the bioaccumulative nature of PentaBDE and its potential risk for children through breast milk decided Member States to implement a Risk Reduction Strategy for PentaBDE which was followed by a European Commission Recommendation requesting marketing and use restrictions.

The EU has recently started the scientific assessment of the Hexabromocyclododecane (HBCD). This chemical is mainly used to in Expanded and Extruded Polystyrene (EPS and XPS) for thermal insulation foams, in building and construction. HBCD is also applied in the backcoating of textiles, mainly for upholstery furniture.

Although not being classified in the EU as a dangerous substance, in 2000 the European Commission Regulation 2268/95 listed HBCD in the Priority List 2 and designated the Swedish government as the Member State rapporteur for the risk assessment.

The rapporteur is expected to issue a draft Risk Assessment Report during July 2003 with the intention of adopting the final report before the end of the year.

1. Overall information & status procedure

Tetrabromobisphenol A (TBBPA) is the main flame retardant used for printed circuit boards to improve fire safety.

TBBPA environmental Risk Assessment was completed in June 2007. No concern was identified in practice by the risk assessment for TBBPA use for the production of printed circuit board laminates.

Emissions of TBBPA when added to ABS plastics can cause local and low risk at plant level for surface water, sediment and soil.

Risks were identified if sludge containing TBBPA is applied to agricultural soil. In practice, however, this does not happen as sludge from user sites in Europe is sent to incineration and controlled landfills.

The human health part of the risk assessment has concluded that TBBPA does not present any risk to human health.

BSEF believes that most of the risks identified for additive application are manageable through a Voluntary Emissions Control Action Programme (VECAP). To date, 100% of TBBPA additive customers in Europe have already committed to control and reduce their emissions.

The UK has drafted a Risk Reduction Strategy (RRS) to address the local risk for soil, water and sediment identified by the Risk Assessment when TBBPA is used as an additive, The RRS recommended a measure to reduce emissions at production plants (IPPC - Integrated Pollution Prevention and Control Directive) as an appropriate tool to control the risk identified at an ABS compounding site in Europe. This plant recently closed.

On 23 October 2007, the RRS for TBBPA was discussed at EU level. The EU RRS officials approved the above proposed strategy.

On 15 January, the European Commission’s Scientific Committee SCHER adopted its opinion on the environmental part of the TBBPA Risk Assessment, which was concluded in June 2007. The SCHER Opinion considers that “the environmental part of the risk assessment of tetrabromobisphenol-A is in general of good quality”.

The European Commission will conclude the whole RA process by publishing in the Official Journal a Commission Decision consisting of the RA conclusions and the RRS.

SCHER - the Scientific Committee on Health and Environmental Risks – is in charge of questions relating to examinations of toxicity and ecotoxicity of chemicals, biochemicals and biological compounds for human health and the environment