Phthalate labelling for medical devices

Medical devices that come into contact with the body and contain phthalates that are carcinogenic, mutagenic or toxic to reproduction (CMR) will have to be labelled as "containing phthalates" under proposals agreed by MEPs and the Council of Ministers on 29 March.

Phthalates are used as plasticisers in PVC and are also common in cosmetics. They are restricted in toys and limits have been proposed for food contact plastics (ENDS Report 376, p 25 ).

The new labelling requirement is one of a series of revisions to two EU medical device Directives.

The European Parliament had argued for a ban on all CMRs in medical devices where safer alternatives were available. But the Council vetoed the proposal as too restrictive and it was dropped.

European plasticiser trade body ECPI said the label would create confusion by implying there was a risk even when this was not the case. "The labelling is likely to unjustly stigmatise phthalates in general," ECPI said in a briefing note to MEPs.

The EU’s expert committee on emerging health risks is reviewing the use of the phthalate DEHP in medical devices. ECPI said it was surprised the decision was made before the committee had reported its findings to the Commission.

Parliament is also assessing a draft risk reduction strategy for DEHP drawn up by Sweden. The strategy recommends banning DEHP in medical devices for vulnerable groups such as babies and kidney dialysis patients. It also wants to restrict its use in food packaging materials.