The report is reluctant to recommend any alternative due to lack of data
The Danish EPA has just published a report in English on alternatives to phthalates in medical devices, called Evaluation of Plasticisers for PVC for Medical Devices.
The report points out that based on other projects, the Danish EPA has to realize the difficulty of substituting PVC in the medical field. However, the Danish EPA, consider it an improvement to health, if the phthalates might be substituted. The Danish EPA finds that there might be a risk in connection with the exposure to phthalates, for which some patient groups might be.
The report of the Danish EPA is a part report of an originally far bigger project, which the EU Commission rejected to support financially several years ago. The extend of the report does only make about one fourth of the original project, that should identify the possibilities of substituting the phthalates in medical devices. The report does only consist of some initial examinations that include a literature search and some trial compounds.
In the project nine commercially available substances are chosen, which have all been subject to a closer analysis. Of these substances there have been mixed nine various compounds. Each of these compounds which have each been tested for a number of physical properties, that shall secure that the compound is homogeneous. Even though the examined compounds are not considered to be quite up to the standard of the phthalate, DEHP, with which is has been compared, the report concludes that none of the nine substances have been rejected as any alternative to DEHP.
However the report concludes that far more data are required before you will be able to substitute DEHP with an alternative. Thus it is characteristic that DEHP is the only substance, for which no data is missing. For all the alternatives in question a long number of data on both environment and health are missing. Besides, all possible alternatives are more expensive to manufacture than DEHP.
The report mentions that it is not expedient to consider the phthalates as one collective group with the same characteristics to environment and health. The phthalates, however, shall be considered a group of various substances with different characteristics as regards both environment as health. In this connection the phthalate DINP it is specifically mentioned as a possible alternative to DEHP. It is also mentioned that the preliminary results of the EU risk assessment of the phthalates are pointing at the fact that especially DINP seems to be an advantageous alternative.
The report is carried out by a working group including both representatives of Maersk Medical A/S (now Unomedical A/S), Totax Plastic A/S, Danish Technological Institute and Hydro Polymers and University of Strathclyde, Scotland.
One third of all medical devices is manufactured in PVC. Approximately 150.000 tonnes of PVC – or approximately 2% of the total PVC production – is used in manufacturing of medical devices.
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