In the News

No Evidence of "Low-Dose Effects" in Recent BPA Studies, Says Germany's BfR

Aug 11, 2010

The German Federal Institute for Risk Assessment (BfR) announced July 29, 2010 that recent bisphenol A (BPA) studies conducted by Stump et al. and Ryan et al. do not demonstrate that BPA has an adverse effect on neurological and behavioral development. The European Food Safety Authority (EFSA) delayed issuing an update on the safety of BPA, in part, to review the Stump study, which was the basis for a temporary BPA ban in Denmark. (For more information, see the PackagingLaw.com article, EFSA Delays BPA Opinion Until September; France Bans BPA in Baby Bottles.)

In a statement on the BPA studies, BfR pointed out that the Stump study was conducted according to the required regulatory standard test design on rats, and included testing of very low dosages. Dietary administration of BPA did not reveal indications of so-called "low-dose effects," BfR noted. Commenting on the Ryan study, the German institute explained that the test design had a particular focus on the investigation of estrogen-sensitive endpoints, and that the results revealed no adverse effects in the low-dose range on behavior and the development of female rat offspring whose dams were treated with BPA during gestation and lactation.

EC's JRC Calls for More Harmonized Approach to Testing BPA

Citing the lack of agreement about the impact of BPA on human health despite a number of risk assessment studies conducted by different regulatory bodies worldwide, the European Commission's (EC) Joint Research Centre (JRC) has recommended that future toxicological studies be conducted based on internationally harmonized test programs. This recommendation is among the conclusions in JRC's Institute for Health and Consumer Protection recently released report, "Bisphenol A and Baby Bottles: Challenges and Perspectives."

The report notes that risk assessment studies conducted over the last 10 years by regulatory bodies in Europe, USA, Japan and Canada were mainly based on studies performed in compliance with regulatory guidelines and good laboratory practice (GLP), using oral administration, large groups of animals, and several dose groups. However, a number of studies with methodology limitations—such as small number of animals, fewer or single dose groups, and non-oral routes of administration—have found adverse health effects from BPA at low dose levels (below those most risk assessments determined were safe).

Noting that most of the current uncertainties regarding human health risks of BPA derive from diverging opinions on the reliability of studies carried out with different methodologies, the authors of the JRC report recommend that globally harmonized BPA test programs be developed, and that these test programs should be carried out under the supervision of an international panel of independent experts. The report added that the Expert meeting to review toxicological and health aspects of BPA called by WHO/FAO will provide an "excellent forum" for discussion. The meeting will be held November 2-5 in Ottawa, Canada (click here for more information on the meeting).