EFSA to Finalise Bisphenol A Opinion in September

The Panel has concluded that the study does not provide evidence of BPA affecting neurobehavioural endpoints included in the study design and would therefore not lead the Panel to consider changing the TDI for BPA.

12 Jul 2010 --- Scientists on the European Food Safety Authority’s CEF Panel have been working on a comprehensive opinion on bisphenol A (BPA) which includes an evaluation of the study investigating the neurodevelopmental toxicity of BPA in rats (Stump 2009), advice on the risk assessment of BPA carried out by the Danish DTU Food Institute, a comprehensive literature review on BPA toxicity, and overall conclusions.

BPA is widely used in the manufacture of polycarbonate plastics, including materials which come into contact with food, such as baby bottles and the lining of tin cans, and has been linked to a number of possible health problems.

For the literature review, the Panel retrieved more than 800 publications and the screening process has taken considerably more time than anticipated. At its Plenary on July 6-8, the Panel spent most of the time discussing elements in the studies and there was insufficient time to finalise and adopt the full opinion.

In a letter to the European Commission, EFSA has indicated that the Panel, in its deliberations to date, would maintain the Tolerable Daily Intake (TDI) for BPA at 0.05 mg/kg bw per day. At the same time, the Panel has identified areas of uncertainty, which were not considered of safety concern, but which merit further consideration.

The Panel has also considered the Stump study, which was the scientific basis on which Denmark banned BPA in materials in contact with food for children aged 0-3 years. The Panel has concluded that the study does not provide evidence of BPA affecting neurobehavioural endpoints included in the study design and would therefore not lead the Panel to consider changing the TDI for BPA. The Panel ruled out the possibility of a low dose effect on learning ability as expressed in the Danish DTU Food Institute risk assessment.

Members of the CEF Panel will continue to work on the opinion through the summer via teleconferences to finalise the full opinion and is scheduled to meet in an extraordinary Plenary in September to complete this work.

EFSA has held consultations with national experts from across Europe, as well as several international risk assessment authorities, on the subject of bisphenol A in recent months, including the design of scientific studies on BPA, toxicological aspects and the strengths and weaknesses of certain individual studies.

Similar issues – as well as details of new risk assessments and studies carried out around the world – have also been discussed with the U.S. Food and Drug Administration (FDA), Health Canada, Food Standards Australia New Zealand (FSANZ),the Food Safety Commission of Japan and the World Health Organisation (WHO). EFSA’s work on BPA will help inform a workshop on BPA being organised by the WHO in November.