Scientific studies
Many scientific studies have been conducted on TBBPA in the framework of the European risk assessment (RA) of the substance, making TBBPA one of the most thoroughly studied flame retardants. There are two parts to the Risk Assessment, Environment and Human Health. The UK Government led both assessments and the overall RA was finalised in June 2008.
The human health part of the RA identified no risks. The environmental section of the RA identified only one local risk at a production plant in Europe, which has since then been closed. The EU Risk Reduction Strategy recommended monitoring emissions of TBBPA through the Integrated Pollution Prevention and Control directive (IPPC). No legislative restriction has been recommended. TBBPA is approved for use in the EU in all of its applications.
The conclusions of the TBBPA EU RA were published in the EU Official Journal on 18 June 2008 and are available on the European Commission's Joint Research Centre website.
All the data produced in the context of the EU Risk Assessment have been used to prepare the REACH registration dossier which was submitted to ECHA in October 2010.
TBBPA is classified in the EU as an H410 substance, which means that it is toxic to aquatic organisms and it has to be labeled to reflect this classification. However, TBBPA loses this classification when it is reacted into the printed circuit board resin, which represents more than 80% of its uses. TBBPA is employed as a starting material that fully reacts to form the epoxy resins of laminates for printed circuit boards. This full integration into the epoxy resin ensures that the final product, flame retarded printed circuit boards, no longer contains TBBPA, leaving the user free from any possible exposure.
A European Commission funded study published in September 2011[1] on the health and environmental risk profile of flame retardants confirmed that for a number of substances, including TBBPA, there is "no need for immediate risk management, based on the approach of the study". This study has shown that, from the over 700 applications of flame retardants identified in consumer products in a domestic environment, 42 flame retardants in little more than 60 applications were relevant for risk assessment for consumer health and the environment. This study has thus shown that, under the current availability of data and by taking account of available risk assessments, 6 flame retardants used in consumer products in a domestic environment, including TBBPA, could be considered not to need risk management measures based on the assessment of the data within the approach of this study, either those publicly available or those obtained through a read-across exercise.
A study was published by the European Food Safety Authority (EFSA) in December 2011 on the exposure of TBBPA and its derivatives in food. It looked at 344 food samples from the fish and other seafood food groups and concluded that "current dietary exposure to TBBPA in the European Union does not raise a health concern". EFSA also determined that "additional exposure, particularly of young children, to TBBPA from house dust is unlikely to raise a health concern".
TBBPA is part, among other substances, of an EU initiative to evaluate potential endocrine disrupting effects. EU scientific experts have reported initial results showing "no major endocrine effects" for TBBPA.
TBBPA is covered by the OSPAR Commission for the Protection of the Marine Environment of the North-East Atlantic. OSPAR has updated the Background document for TBBPA in 2011. Based on the REACH criteria, TBBPA only meets the persistence criteria for the PBT assessment. Overall, TBBPA is not considered to meet the REACH PBT criteria. However, in the OSPAR Framework the PBT criteria are more conservative than those used by the EU and therefore TBBPA is considered as a priority substance under OSPAR.
For more details, please see science centre scientific studies.
[1] ARCADIS EBRC Belgium "Study of flame retardant substances in consumer products in domestic environments" - http://ec.europa.eu/consumers/safety/news/flame_retardant_substances_study_en.htm
