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The Weight of Evidence on DEHP: a joint EEN and HCWH publication

Although DEHP (di(2-ethylhexyl) phthalate) is hazardous to people’s health, it is still widely used in medical devices within many European hospitals and health care facilities.

Due to the environmental health risks it brings throughout its life cycle, DEHP-softened PVC has been criticised by the scientific community, governments and NGOs for more than 10 years, and many statements exist expressing this concern. When the EU decided to classify DEHP as a health hazard and label it as "toxic" with a "skulls and crossbones" symbol, global discussions on reducing exposure to DEHP gained further momentum.

Studies undertaken by US, Canadian and EU governments have all concluded that DEHP exposure is a real concern to certain patient populations and subsets of the general population. In particular, healthy infants and toddlers, pregnant and lactating women, and patients undergoing certain medical procedures are vulnerable. All of the governmentled studies recommended action to reduce DEHP exposure in vulnerable populations. Despite the results of these scientific studies, the use of DEHP-softened PVC medical devices continues. As is the case with many other chemicals, the lack of evidence of harm in humans is used as proof of safety and the European regulatory authorities have so far failed to protect citizens.

Recommendations for Action

Health Care Without Harm and EPHA Environment Network have published a leaflet that can be downoaded below recommending that European and national regulatory authorities:
* Finalise the Risk Assessment and Risk Reduction Strategy on DEHP and include a recommendation to limit risks from DEHP exposure in medical devices.
* Restrict the use of DEHP in medical devices by amending EU Directive 93/42/EEC concerning medical devices. Immediately ban the use of DEHP in products used for medical procedures where long-term exposure can lead to an increased risk of developmental and reproductive disorders for certain patient groups, or to their offspring, and where safer alternatives are already on the market.
* Implement the substitution principle and phase out the use of DEHP in all medical devices where safe alternatives are readily available on the market. The same precautionary approach that was taken with certain toys and cosmetics, where DEHP has been banned from use, should be applied to medical devices.
* Ensure that the REACH proposals for the regulation of chemicals will require the mandatory substitution of ’substances of very high concern’ when a safer alternative is already available on the market, in order to reduce the public’s general exposure to hazardous chemicals in the environment and from consumer products.


Attachment logo  The Weight of Evidence on DEHP


Written on 4th July 2005.


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