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Towards non-toxic healthcare: HCWH Europe reports on alternatives to phthalates and BPA in medical devices

HCWH press release

28.04.2015 |Health Care Without Harm Europe (HCWH)

As WHO/Europe Member States meet to discuss the Parma Declaration on Environment and Health, a report calling for a phase-out of endocrine disrupting chemicals from medical devices is released by Health Care Without Harm (HCWH) Europe.

Brussels, 28 April 2015 — Today marks the start of the European Environment and Health Process Mid-term Review (EHP-MTR) in Haifa, Israel, where WHO/Europe Member States will evaluate progress and identify the next steps towards meeting the goals of the Parma Declaration on Environment and Health.[1] HCWH Europe marks this occasion with the release of its new report Non-toxic Healthcare: Alternatives to Phthalates and Bisphenol A in Medical Devices which highlights that patients are routinely exposed to endocrine disrupting chemicals (EDCs) through medical devices.

The report provides evidence of the potential hazards  these substances pose to human health and the environment, presents an analysis of safer alternatives available on the market and calls for a phase out of phthalates and bisphenol A (BPA) in medical devices.

Why is there concern about medical devices?

Medical devices are vital in healthcare but they can contain harmful substances in their composition, such as phthalates and BPA, that may leach out into the patient’s body. Phthalates are commonly used as softeners in PVC-based medical devices while BPA is used in a wide variety of plastics with applications in the medical device industry, such as feeding tubes and IV connectors. The presence of phthalates and BPA in medical devices is worrying as they are endocrine disrupting chemicals (EDCs). These can interfere with the normal functioning of our hormonal system and harm the body’s physiological and developmental processes throughout our life. Growing scientific evidence is linking EDCs exposure to a wide range of abnormalities and illnesses.

Exposure to phthalates has been linked to reduced ano-genital indices, reproductive alterations (low sperm concentration, endometriosis, hypospadias, shorter pregnancy duration, etc.), changes in neurobehaviour in neonates, infants and children, cholestasis, dermatitis, heart diseases and perturbations in inflammatory responses. Regarding BPA, a recent review has identified more than 75 studies where exposure was associated with health effects in humans, including reproductive effects (erectile dysfunction, miscarriages), and thyroid, immune and metabolic diseases (diabetes).

Of particular concern is the impact of exposure on vulnerable patients, including those who undergo multiple medical treatments or face chronic exposure over extended periods. The recent opinion on the safety of the use of BPA in medical devices by the European Commission’s Scientific Committee on the Emerging and Newly Identified Health Risks (SCENIHR) concluded that risks for adverse effects of BPA may exist, especially for neonates in intensive care units, infants undergoing prolonged medical procedures and dialysis patients, and that the possibility of replacing BPA in these products should be considered, against their efficiency in the treatment and the toxicological profile of the alternative materials.

The unborn, neonates and children are of special concern as these groups are being exposed to hazardous chemicals at a highly vulnerable moment (window of vulnerability), when various aspects of their development can be altered, potentially with lifelong consequences.

Why release this report?

HCWH Europe’s report supports the precautionary principle and approach that substitution is the best course of action when there is concern about the safety of chemicals contained in consumer products. . This report is a plea for policymakers and governing bodies to demand the phase-out of hazardous chemicals from medical devices and the adoption of a new regulation on medical devices that eliminates phthalates and BPA from healthcare. A new EC regulation proposal on medical devices is currently being debated by Member States. This is a vital opportunity to protect the environment and human health from the risks of exposure to hazardous chemicals. The risks to our health are simply too great to ignore.

“Better alternatives are available for almost all products used in daily healthcare. It is then a matter of choice: do we choose better alternatives or do we choose to ignore the mounting evidence of potential danger to the patients we are trying to treat?” states Dr Gavin W. ten Tusscher, paediatrician at the Westfriesgathuis Hospital in the Netherlands.

“The healthcare sector has a duty to protect patients, including vulnerable groups, from exposure to potentially harmful substances. Healthcare must not only cure illness, but it must also prevent it. That means using safer alternatives to phthalates and BPA to reduce exposure and potential illnesses in the long term,” adds Grazia Cioci, Policy Director at HCWH Europe. “This could be facilitated and incentivised by ambitious European legislation that requires the phase out of EDCs contained in medical devices when safer alternatives exist, with the aim to guarantee non-toxic healthcare for patients, staff and the environment.”

Read: Non-toxic Healthcare: Alternatives to Phthalates and Bisphenol A in Medical Devices

[1] The Parma Declaration includes the EHP’s first-ever time-bound goals on the environment and health. Among the goals of the Parma declaration is tackling concerns raised by persistent, endocrine-disrupting and bio-accumulating harmful chemicals and nano-particles; and by novel and emerging issues. This was ratified by Member States in 2010 at the Fifth Ministerial Conference on Environment and Health in Parma, ltaly.


Rosalind Simpson

Communication and Press Officer, Health Care Without Harm Europe

+32 483 716 786

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