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EFSA rejects bisphenol A concerns, reconfirms TDI

By Rory Harrington, 01-Oct-2010

Related topics: Quality, Safety, Hygiene, Packaging Technology, Safety & Regulation, BPA & food contact materials

The European Food Safety Authority (EFSA) said there is no new evidence to suggest the tolerable daily intake (TDI) for bisphenol A (BPA) needs to be changed as it reconfirmed that current levels of exposure pose no threat to human health.

The food safety agency said it would be maintaining the TDI of 0.05mg/kg/bodyweight after its expert panel spent six months evaluating hundreds of studies on BPA. Yesterday's decision ended months of speculation and reaffirmed EFSA’s two previous opinions on the substance in recent years.

“Following a detailed and comprehensive review of recent scientific literature and studies on the toxicity of bisphenol A at low doses, scientists on the EFSA CEF Panel conclude they could not identify any new evidence which would lead them to revise the current Tolerable Daily Intake for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion and re-confirmed in its 2008 opinion,” said the body.

Temporary TDI?

But the food safety watchdog acknowledged there had been dissent among its 21-member CEF panel. Concerns had been raised by one member who recognised that some recent studies “pointed to uncertainties regarding adverse health effects below the level used to determine the current TDI”.

While the expert agreed with the panel’s general view that the research could not justify lowering the TDI, the member recommended that the current TDI should become a temporary one, said the agency.


EFSA said some studies had reported harmful effects on animals exposed to BPA during development at levels significantly below those used to determine the current TDI. These included biochemical changes in the central nervous system, effects on the immune system and enhanced susceptibility to breast cancer. But the panel said that such research had “many shortcomings” and their relevance to human health could not be assessed. It added that should new relevant data become available in future, it would re-examine its opinion.

Neurobehavioural toxicity rejected

The body also dismissed concerns over the neurobehavioural toxicity of BPA raised in the Stump study – declaring the evidence to be unconvincing. The research was the basis upon which the Danish government earlier this year banned BPA in food contact materials for young children citing uncertainty over the effects of the chemical on learning ability.

The CEF panel claimed there were failings in the analysis of the Stump data and said this was confirmed after further evaluation from EFSA’s Assessment and Methodology Unit. The committee said the high variation in its results rendered the research “inconclusive with respect to learning and memory and of limited value for the risk assessment of BPA”. EFSA added that its review of the scientific literature had failed to provide convincing evidence that BPA “has any adverse effects on aspects of behaviour, such as learning and memory”.

Bisphenol A is a chemical used as a monomer in polycarbonate plastic and epoxy resins – two food contact materials used in the manufacture of baby bottles and food and drink can linings respectively. Its continued use is a matter of fierce debate, with scientific evidence divided on the issue. In January 2010, the US Food and Drug Administration (FDA) said the substance was safe at current exposure levels. It also recommended that children and pregnant women reduce their exposure to the substance and that industry should seek to develop BPA-free materials for use in food contact materials.

Click on the link below to view the full EFSA opinion