Labelling of medical devices containing DEHP

With effect from March 2010, all medical devices containing phthalates must be labelled as such for use in the European Union. This is in accordance with the consolidated Medical Devices Directive Devices Directive 93/42/EEC, as amended by Directive 2007/47/EC.  

The European Committee for Standardisation, CEN, was asked to develop a European standard to meet the new phthalate labelling requirement and to issue specific guidelines on labelling medical devices containing phthalates. Called prEN 15986, the document has been adopted by CEN as European Standard and has been available to the National Members for publication since 2 March 2011. This standard was cited in the Official Journal of the European Union under Directive 93/42/EEC on 13 May 2011.

The symbols which have to be used display the label "PHT" to note the presence of a phthalate inside a round- edged triangle. The specific phthalate is listed either on the side or below the PHT and triangular symbol. Examples of the proposed symbols indicating the presence of DEHP are:    

Labelling of medical devices or parts of medical devices containing particular phthalates is required because some lower molecular weight phthalates have been classified as CMR 1 & 2, i.e. they could exhibit carcinogenic, mutagenic or reprotoxic/developmental effects.

The European Standard document points out that not all the reproductive and developmental toxicity of phthalates to the human body have been confirmed. However, it has been suggested that precautions be taken to limit the exposure of humans particularly that of high risk patient groups.

From a user's point of view, a symbol conveys information in order that the user may assess the suitability of the medical device in order to mitigate risks to the patient.

Due to the fact a number of phthalates with known and unknown biological effects exists on the market this European Standard includes only one symbol for medical devices "containing particular phthalates". When the user has been informed that the product contains those particular phthalates precautionary actions can be found in the instruction for use. Annex B provides information about the use of the general prohibition symbol.

More information on the labelling requirements can be found on the CEN website