1. Political and toxicological reasons for labelling requirements of DEHP-containing medical devices Ole Grøndahl Hansen PVC Information Council Denmark Labelling and packaging compliance conference 23 – 24 September 2008 Brussels

2. Content of Presentation  General overview of PVC use in medical devices  EU perspective on PVC  The European Parliament and DEHP in medical devices  The new labelling requirements  EU scientific committee on DEHP in medical devices  Conclusions

3. others 11% PP 13% PS 21% PE 29% PVC 29% Use of plastics in the health care sector 85.000 tonnes of PVC used for medical devices per year in EU Total consumption of PVC in Europe is 7.000.000 tonnes

4. PVC medical applications The low costs and the high performance of PVC made it possible to manufacture single-use devices in the late 1950’s. The two main application areas for PVC devices are flexible containers and medical tubing: ie. urine bags, ostomy bags, blood bags etc and different kinds of tubing for catheters etc. Single-use of medical devices resulted in a revolution within the health care sector. The PVC based devices improved medical safety by reducing the risk of life-threatening infections caused by the multiple-use of traditional devices.

5. The EU perspective on PVC  Initiated by the Danish Environment Commissioner Ritt Bjerregaard, the EU-systems gets involved in the PVC issue in the late 90’s.  A Horizontal initiative, a Green Paper on PVC and a EU-resolution from the Parliament dominate the PVC debate around the turn of the 21’st century.  In 2000 the PVC industry establishes the Voluntary Committment of the whole PVC supply chain called Vinyl 2010. Vinyl 2010 is taking responsible care of emissions, recycling, additives and new waste management technology.

6. New knowledge and new technology changed the debate THEN: In the past badly driven hospital incinerators caused acid rain and dioxin emissions. This was partly due to the chlorine content in the hospital waste. Although PVC is only one of the contributors of chlorine PVC was accused of being the main cause of these emissions. NOW: Because of new incineration technologies and more stringent regulations, PVC no longer plays any role in the creation of acid rain and cannot be accused of being the cause of dioxin emissions. The dioxin debate during the last ten years showed that the role of PVC is inferior to incinerator design and operating conditions in the creation of dioxins from waste incinerators.” The concern of dioxin in association with the incineration of medical devices has diminished dramatically during the last ten years. This is partly because of new scientific knowledge, partly because of the use of new incineration technology. However, neutralisation residues resulting from PVC incineration are still of concern to some stakeholders.

7. EU-Parliament voting In 2007 there is a vote on PVC in the European Parliament. 662 vote against a PVC directive, while 17 vote for. PVC is not an issue anymore in the European Parliament. According to the EU Commission, the reason is the industry’s voluntary committment: Vinyl 2010

8. A shift from environmental to health issues  Earlier PVC as a material was of concern because of environmental issues. Now the concern is connected to health and consequently the use of additives. The use of phthalates in medical devices is now in focus.

9. Political discussions  Revision of Medical Device Directive  Politicians inspired by the directive on toys  Environmental Committee voted for a ban of CMR-substances in medical devices  Compromise between EU-Commission, the Council and approved by European Parliament: 645 voted for the proposal, 15 against.

10. The compromise  In 2007, EU institutions agreed to the labelling of medical devices containing phthalates with hazard classification (CMR): Medical device manufacturers will have to justify use in applications for children or pregnant women in technical documentation Medical device manufacturers will have to justify use in applications for children or pregnant women in technical documentation EU to mandate European standardisation body (CEN) to establish standard for labelling by October 2008 EU to mandate European standardisation body (CEN) to establish standard for labelling by October 2008 In mid-2010 medical device industry to comply with labelling provisions In mid-2010 medical device industry to comply with labelling provisions

11. Timeline  CEN received draft mandate from the European Commission and expect to receive the final version by 11 October 2008  According to DG Enterprice the label will be developed quite quickly, possible in one year, because it is not a controversial issue.  According to CEN, timeline to develop standard is usually three years but they agreed that timing is likely to be shorter because of the requirements in the EU revised Directive on Medical Devices and because there is good collaboration between stakeholders.

12. What will the label look like? Of course we cannot say yet! However the plasticiser industry is working together with the medical devices manufacturers and they have suggested some proposals. One proposal suggests a circle containing two numbers (3.2). 3 stands for PVC and 2 stands for reprotoxic. A code like this eliminates the need for translation and avoid any specific mention of PVC, DEHP or phthalates.

13. Reactions from stakeholders  Health Care Without Harm: ”The legislation should have gone further and banned the use of toxic chemicals from medical devices where suitable alternative exists.”  The Plasticisers’ Industry (ECPI): ”Labelling requirement is unnecessary, because the EU system has already appointed a competent body to consider the use of DEHP in medical devices.”  And what does this competent body say?

14. Latest study from EU Commission Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) THE SAFETY OF MEDICAL DEVICES CONTAINING DEHP PLASTICISED PVC OR OTHER PLASTICIZERS ON NEONATES AND OTHER GROUPS POSSIBLY AT RISK Approved for public consultation by the SCENIHR during the 19th plenary of June2007

15. SCENIHR conclusions (I)  There is limited evidence indicating a relation between DEHP exposures and specific effects in humans. However: New information indicates that there are reasons for concern for male neonates. Other population groups at risk are those requiring repeated medical procedures and male infants and male foetuses of pregnant women.

16. SCENIHR conclusions (II)  There are alternative plasticisers to PVC and also non-PVC alternative materials available (The non-PVC alternative materials were not evaluated in the study). For the alternative plasticisers a generic exposure assessment could not be performed, due to lack of data.  Some alternatives may be suitable to replace DEHP in certain medical devices, while for other devices it may be difficult to obtain the same functionalities as PVC plasticised with DEHP  The risk and benefit should be carefully evaluated according to established protocols, for each individual medical device and each medical procedure in which the alternatives are intended to be used.

17. Conclusions  DEHP is NOT banned in medical devices, however labelling will be required and documentation for use in sensitive application needed.  For many sensitive medical applications alternatives to DEHP now exist. The benefits of a PVC product can be maintained by choosing among different kinds of plasticisers. DINCH, Soft ’n Safe, adipate plasticisers, trimellitates and polymerics are good examples.  More information on both the SCENIHR-report and on the labelling issue can be found in the pan European magazine Medical Device Technology (Oct 2007 issue and Oct 2008 issue)