Labeling Symbols Recommended for Devices with Phthalates

(QMN Weekly Bulletin)

To help manufacturers of devices containing certain phthalates comply with the new labeling requirements of the revised Medical Devices Directives (MDD), Eucomed has released proposed symbols that can be used until an official labeling standard is adopted.

The MDD, which goes into effect March 21, 2010, requires specific labeling when phthalates that are classified as carcinogenic, mutagenic or toxic to reproduction are an integral part of a device intended to administer or remove medicines, body fluids or other substances or intended to transport and store such fluids or substances, Eucomed says in a statement posted recently on its website.

Plasticizers that must be identified include bis(2-ethylhexyl)phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP), which have been classified in the EU as toxic for reproduction.