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| Phthalate Labelling Of Medical Devices |
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O.Grondahl Hansen
PVC information Council, Copenhagen, Denmark
Medical Device Technology, October 2007
In the European Union, the use of Di(2-ethylhexy)phthalate (DEHP) in medical devices has been under serious pressure. A proposed ban on its use was avoided and changed into a labelling requirement. This article reports the dramatic political development that resulted in this requirement and highlights some new alternative plasticisers that can be used if poly(vinyl chloride) devices without DEHP are required in the future.
A total ban desired by some
The revision of Medical Devices Directive (MDD) (93/42/EEC), which regulates the marketing and use of medical devices in Europe, has meant that the future use of Di(2-ethylhexyl)phthalate (DEHP) in medical devices that has been subject to intense discussions at the highest level in the European Union (EU ) for the past six months. When the MDD was undergoing a review by European Parliaments Environmental Committee, the German Green Party member of the European Parliament, Hiltrud Breyer, proposed that the use of so called carcinogenic, mutagenic or toxic to reprotoxic (CMR) substances should be banned in future medical devices. CMR substances are those that are classified as carcinogenic, mutagenic or toxic to reproduction. DEHP is classified as a category 2 reproductive toxin, thus it is a CMR substance. If the proposal had been accepted, it would have meant that DEHP would no longer be permitted in medical devices. It is important to note that DEHP is still the most widely used plasticiser in poly(vinyl) chloride (PVC) based medical devices and that PVC devices make up almost one third of all medical devices. It was due to Breyer that the following amendment to the MDD was proposed to the environmental committee: Devices shall not contain substances classified as carcinogenic, mutagenic or toxic for production, unless no alternative devices without such substances are available.
It no surprise that Breyer wished to have the use of CMR substances banned in medical devices. She had previously argued that regulation on the use of phthlates included in the toy directive should also apply to the use of phthalates in medical devices. When her proposal was put before the Environmental Committee, it was evident that Breyer was not alone in this view. On 11 October 2006, the Environmental committee accepted her proposal for medical devices by 26 votes for 24 votes against.
However a proposal that is accepted by the European Parliaments Environmental Committee does not necessarily mean that the same proposal with the same wording will later be put to the vote and accepted by the European Parliament. Before proposals are put to the vote, long and intense discussions take place among the stakeholders involved. This is what happened with Breyers proposal.
New labelling requirement
As a result of input from stakeholders, representatives of the European Commission, the EU Council of Ministers and the European Parliament reach an agreement on the issue on 6 March 2007. The agreement stated that in line with the essential requirements of the MDD, manufacturers should avoid the use of substances that may possibly compromise the health of patients, in particular of substances which are carcinogenic, mutagenic or toxic to reproduction, and should, as appropriate, strive at developing alternative substances or products with a lower risk potential. To achieve this objective the compromise agreement said that European Commission should give a mandate to CEN, the European standards body to specify a specific label for phthalate-containing devices.
In stead of banning the use of CMR substances in medical devices, the European Commission, the EU Council and the Parliament proposed that medical devices containing phthalates should be labelled. The objective of course is that labelling will encourage the substitution of DEHP without imposing a ban on the substance. On 29 March 2007 members of the European parliament vote overwhelmingly in favour of this proposal. The vote showed that 645 members of the parliament voted for it. 15 against it and 4 abstained.
The agreed revision of the MDD, which contains the labelling requirement, will be implemented across the EU in 2007. However, the labelling requirement will not come into force until 2011. It has not yet been decided where the label should be placed: on the device or on the packaging. CEN will propose the location and the European Commission will make the decision on its placement.
On the day of the vote, 29 March 2007, The European Commission published a press release stating that it was satisfied with the outcome of the vote on the revision of the MDD. The safety of medical devices will now be significantly improved it said, because, there will be stricter rules for the use of potentially toxic materials, for which adequate labelling will be required.
Continuing disagreement
Despite the fact that an overwhelming majority of European Parliamentarians voted in favour of the labelling requirement, a disagreement among stakeholders on the issue still exists. In a press release issued on 29 March 2007, Breyer said while these provisions are certainly improvements on the current situation, clearly only a ban on these toxic substances will provide the necessary protection. This position is in line with the international organisation, Health Care Without Harm(www.noharm.org/europe) whose press release also published on 29 March 2007 said that the legislation should have gone further and banned the use of toxic chemical from medical devices where suitable alternative exists.
Phyhalate industry perspective
The European council for Plasticisers and Intermediates (ECP) (www.epci.org) argues that the labelling requirement is necessary, because the EU system has already appointed a competent body to consider the use of the DEHP in medical devices and that this body is to develop recommendations on future use. In principle, the phthalate industry considers it to be problematic that European Parliamentarians are regulating a highly complicated area, before the European Commissions experts have had the opportunity to make their opinion. The Commission has appointed the Scientific Committee of Emerging and Newly Identified Health Risks (SCENIHR) to give its opinion on which alternatives may be used, if it is presumed that there is a risk from the use of DEHP. Currently, SCENIHR has decided that prior to the publication of its final recommendations on the use of DEHP, its proposal will be given a public hearing. Thus, it is likely to be towards the end of 2007 before the industry receives a final scientific opinion from SCENHIR.
In addition to criticising current procedures, phthalate industry has said in a briefing note sent to European Parliamentarians on 8 March 2007 that, there is at this stage no scientific basis for the proposed measure. It appears to have been inserted for reason of political expediency without reference to any underlying evidence or scientific justification. The labelling infers that there is a risk from phthalates of which the patient or user should be aware and creates unnecessary fears and uncertainty for all plasticisers markets.
Effect on users
The main question now is what will happen when the markets begins to see the phthalate labelling on medical devices. Will the market ignore the label or will it begin to require devices without DEHP? At the moment this is not known. It is extremely important to bear in mind that it is first of all the PVC polymer and not the phthalate plasticiser that enables the medical device industry to manufacture low cost medical devices of high quality. In other words, the phthalate plasticiser can be substituted in PVC- based medical devices without losing the many benefits that PVC devices provide.
Other plasticisers
Alternatives to phthalates in PVC-based medical devices do exist. Some have existed for years, for example adipates, citrates and trimellitates, and some interesting new ones have been developed recently. Two of the new ones on the market are BASFs hexamoll DINCH (www.basf.com/plasticizers/products.html) and Daniscos Softn Safe (www.danisco.com).
A new plasticiser for sensitive application such as PVC-based medical devices is not developed over night. Ten years ago BASF started a project called sustainable plasticisers to find alternative plasticisers for PVC applications such as medical devices, toy and food contact. A reason for starting the project was the public discussion about phthalates in toys, which peaked at the end of the nineties. The new plasticiser from BASF is based on Diisononyl phthalate, which is transformed into a new molecule called Hexamoll DINCH. From the start, this material has been subject to a great amount of toxicological testing; in toatal, 5 million have been spent on this testing. According to a press release from BASF dated 11 October 2006, all tests confirmed the excellent toxicological profile of Hexamoll DINCH, which underlines its suitability for sensitive application such as medical devices. While the new plasticiser was being developed, BASF decided to build a plant that came into operation in 2002 with a capacity of 25 000 tonnes. In 2006, the company decided to increase the annual capacity to 100 000 tonnes and this expansion was completed in May 2007. Hexamoll DINCH has now been successfully introduced for the production of PVC-based medical devices such as internal feeding sets, tubing for haemodialysis, and bags and gloves. Tests are now being conducted for more applications, including blood bags.
The Danish food manufacturer, Danisco has also developed and been licensed to market in the EU a new plasticiser for PVC called Softn Safe. Danisco started developing the product almost ten years ago. The material is based on vegetable oil that is already in use as food ingredient in margarine and chocolate. The official product launch took place in February 2005. Its main applications are sensitive PVC products such as medical devices, toys and tubing for the food industry. According to a press release from the company dated 20 March 2006, there is a great consumer interest in the material and it has therefore decided to invest 5 million in increasing production capacity of the new plasticiser to 5000 tonnes annually. According to Danisco, potential new customers in the plastic industry have tested the product and confirm that the new plasticiser can be used without changes to their existing production equipment. This is also the case with BASFs product. Danisco reports that the price of its material is three to four times higher than the cost of phthalates.
A secure PVC future
It is difficult to predict how the market will react when medical devices containing phthalates are labelled from 2011. But it is important to stress that there are many alternatives on the market that can do the job of DEHP. The health care sector can still benefit from all the positive technical and economical properties of PVC in the future, with or without DEHP.
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