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FDA BPA assessment says bisphenol-a safe in food-contact products for infants, humans
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August 2018

BPA Causes Confusion, Study Says

August 2018

There are likely no studies reporting that BPA (Bisphenol A) causes confusion - but it is true that BPA is a confusing subject; you're forgiven if you've been confused by the conflicting statements you've read about BPA in recent years.

The European Food Safety Authority (EFSA) concluded that "BPA poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels." That conclusion was the result of a comprehensive scientific evaluation conducted by a panel of experts commissioned by EFSA.

Put more simply, BPA is safe, which is exactly what the U.S. Food and Drug Administration (FDA) says on its website based on its own comprehensive evaluation: "Is BPA safe? - Yes." A recent statement from FDA on the CLARITY study noted: "our initial review supports our determination that currently authorized uses of BPA continue to be safe for consumers." (The FDA conducted the CLARITY study with FDA senior scientists in its own laboratory, to resolve remaining uncertainties about Bisphenol A safety.)

So, there's not much confusion about what EFSA and FDA say about BPA safety. And they're not the only ones - government authorities around the world have said similar things, based on results of its own BPA research.

But here's where it gets confusing. Though EFSA stated "BPA poses no health risk," the European Chemicals Agency (ECHA) concluded that BPA is a "Substance of Very High Concern" (SVHC). How can it be that BPA is safe, and a SVHC at the same time? Is one of these statements wrong?

The reason for the discrepancy is that ECHA is doing something quite different from FDA and EFSA. The discrepancy is so large that you might even say ECHA is not telling you the whole story. Even worse, they're not telling you the part of the story that may be most important for consumers to know.

Both EFSA and FDA evaluate the safety or risk of a chemical in the way that you actually may be exposed to that chemical. The evaluation starts with consideration of hazards, which are intrinsic properties of a chemical that are independent from how, or even if, anyone contacts that chemical. Importantly then, safety or risk evaluations also include consideration of exposure, in particular the level of the chemical that consumers actually experience.

Considering exposure is very important. To illustrate why, you can safely eliminate your headache by taking two aspirin. But taking a whole bottle of aspirin will almost certainly harm you, perhaps even take your life. Aspirin is safe (i.e., very low risk) at the levels that consumers normally experience; it may not be safe if you take too much ("the dose makes the poison" as the saying goes), but that's not really a concern for typical exposures.

In contrast, ECHA's conclusion on BPA is based only on an assessment of hazard properties - without any consideration of typical consumer exposure. By itself that conclusion may be of some academic interest, but it is incomplete and not particularly informative for consumers since it completely overlooks the well-established fact that human exposure to BPA is extremely low.

What we most care about is the safety of a substance under the conditions of typical human exposure. In other words, is it safe - or does it present a risk when we use it? The answer to that question for BPA, as clearly stated by FDA, is yes - Bisphenol A is safe. In that light, it might be more appropriate to designate BPA as a Substance of Very Low Concern (SVLC), meaning there is a very sound scientific basis to support its safety.



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