Regulatory Focus™ > News Articles > Medical Devices Containing BPA Could put some Patients at Risk, EU Committee Finds

Medical Devices Containing BPA Could put some Patients at Risk, EU Committee Finds

Posted 05 March 2015 | By Michael Mezher 

Medical Devices Containing BPA Could put some Patients at Risk, EU Committee Finds

A report authored by one of the European Commission's scientific committees has found that the use of bisphenol A (BPA) in medical devices may pose some risk to vulnerable patient populations, including those patients for whom long-term contact with medical devices is necessary.


BPA is a widely used synthetic compound that is found in plastics used to make a diverse range of products, including water bottles, food wrappers, dental fillings and medical devices.

Despite its widespread use, the use of BPA has not been without controversy.

Scientists began raising concerns that BPA exposure could be associated with a rise in certain cancers and reproductive issues in the 1990s. By the mid-2000s, regulators in the US and EU began to formally investigate whether BPA use posed health risks to consumers.

In 2006, the European Food Safety Authority (EFSA) conducted a risk assessment on BPA use and determined a tolerable daily intake (TDI) of 0.05 mg/kg of body weight per day.

The safety of BPA use in applications where it is in contact with foods has been called into question by other regulators as well. Subsequent reviews conducted by the US Food and Drug Administration (FDA) and EFSA found inconclusive evidence that the use of BPA in food contact applications poses serious health risks. Both FDA and EFSA acknowledge that there are still uncertainties in the scientific literature, but found it unlikely that BPA use in food contact applications is a risk at current intake levels.

Out of concern for infant safety, several jurisdictions, including Australia, Canada and the EU, have banned BPA use in baby bottles.

SCENIHR’s Opinion

In January 2014, the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) launched a public consultation on its preliminary opinion regarding BPA use in medical devices. The opinion focuses on more vulnerable population segments, such as pregnant or nursing women and infants.

In its review, SCENIHR used the TDI set by EFSA as a base for its risk assessment. The committee found that BPA use in dental materials “poses negligible risk.”

However, the opinion finds that risks may exist from prolonged non-oral exposure routes in infants and dialysis patients. The committee recommends that companies use alternative materials that do not leach or contain BPA in medical devices, but says the benefits of the devices must be weighed against any risk of BPA exposure.

The committee received comments from 14 organizations, including industry associations, medical device companies, professional organizations and national regulatory authorities.



Tags: bisphenol A, BPA, EFSA

Categories: Regulatory News

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