The French agency responsible for the safety of medical products, AFSSAPS, has advised medical professionals against using DEHP-containing devices in certain procedures and with patient groups considered at high risk of harm from phthalates.

Device manufacturers will also be required to mention the presence of phthalates in information given to the device user.

The measures are being put in place to cover the time period before entry into force in 2010 of new EU laws which require medical devices containing substances suspected of being carcinogenic, mutagenic or reprotoxic to be labelled as such. DEHP is one of these substances.

AFSSAPS has issued its advisory in the context of formal recognition from the French government that chemical pollution is a possible cause of declining fertility, increased rates of genital malformations and rise in testicular cancer.

French healthcare NGOs CNIID and C2DS welcomed the move, stating it will help to accelerate the substitution of phthalate-softened PVC medical devices for safer alternatives.

Since Nicolas Sarkozy took the French Presidency, the French government has been active in introducing a range of regulations designed to reduce the incidence of illnesses linked to environmental factors.



Health and Environment No.14, May 2009 (formerly HCWH Europe Newsletter)