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29.03.2007

Toxic substances 

Highly toxic substances in medical devices to be labelled under new legislation

Toxic substances should have no place in medical devices, when safer alternative devices exist. Medical devices are in constant direct contact with the body and should not endanger the health of patients.One particular offender is the use of soft PVC in medical devices, which usually contain high concentrations of the toxic softener DEHP (a phthalate that is toxic to reproduction).
A first reading agreement between the European Parliament and the Council on revising the medical devices directive was adopted by the EP today. Under the agreement, all medical devices that include substances (PVC softeners) which are carcinogenic, mutagenic or damaging to reproductive organs (CMR substances), will have to be labelled to reflect this. Following the vote, Green MEP and shadow rapporteur Hiltrud Breyer said:

Toxic substances should have no place in medical devices, when safer alternative devices exist. Medical devices are in constant direct contact with the body and should not endanger the health of patients.One particular offender is the use of soft PVC in medical devices, which usually contain high concentrations of the toxic softener DEHP (a phthalate that is toxic to reproduction). The EP had originally sought a ban on the use of highly toxic 'CMR' substances where safer alternatives exist and we regret that this was not included in the final agreement, following the resistance of Council. Read more...

MEP Hiltrud Breyer's press release download.