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July 04, 2008 Est 1999 Scotland's award-winning independent newspaper
EU investigates chemical that may harm boys
DEHP banned in toys but used in medical devices

EUROPEAN UNION officials have launched an investigation into the use of a chemical in a wide range of medical devices amid fears it could cause harmful health effects in baby boys.

The chemical, called DEHP, is added to PVC plastic to make it softer and more flexible. It is one of a group of chemicals called phthalates and is found in medical products such as blood bags, catheters, and tubing.

But research has shown that it can leach from PVC devices into fatty solutions such as blood or nutrition formulas. In animal studies, DEHP has been found to cause reproductive birth defects and infertility at certain doses.

Now an initial report into the use of the additive by a scientific committee that advises the European Commission (EC) has concluded that the high exposure during some medical treatments "raises concerns", particularly for baby boys. It warned that in many cases the exposure to DEHP may be "significant" and exceed the toxic doses observed in animal research.

A consultation has been launched on the safety of DEHP and its alternatives in medical devices by the EC, which could lead to new legislation.

The move has been welcomed by campaigners, who also pointed out that the European Union has already banned the use of DEHP in cosmetics and in toys for children under three.

Cestmir Hrdinka, executive director of Healthcare Without Harm in Europe, said that some countries - including Canada, Germany and the US - recommended that hospitals should use alternatives to devices with DEHP where available.

"The EU banned this chemical in cosmetics because we know that DEHP has an adverse effect on humans, so we argue that the same logic should be applied to medical devices," he said.

"For some devices such as IV bags and tubings we have alternatives available, we can use other plastics that don't use the DEHP and so we advocate that we should use these alternatives."

Jeni Mackay, the Scottish campaigns co-ordinator of Communities Against Toxics, said: "The EU banned phthalates in plastic toys for kids under the age of three. If you are using medical equipment with the same chemicals in them on infants, for me that causes a problem."

The use of DEHP in medical devices was examined five years ago by the EU Scientific Committee on Medicinal Products and Medical Devices (SCMPMD), which concluded that the advantages of using the chemical outweighed the disadvantages.

But since then new evidence has emerged on the possible effect of DEHP on reproductive abnormalities - SCMPMD's successor body, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), said: "Recent information on the exposure of the general population and especially of the vulnerable groups raised a concern on the potential toxicity of DEHP.

"Vulnerable groups are male infants, male offspring of pregnant and breastfeeding women undergoing certain medical procedures that may result in general in short-term exposure to relatively high levels of DEHP."

The EC's online consultation on the issue will run until November 26. A spokesman said responses would be assessed before deciding the next steps.

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