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4 September 2012

Letter to Astrid Krag, Danish Minister for Health,

concerning phthalates in medical devices

Dear Astrid Krag

Denmark, personified by Ida Auken, Minister for the Environment, is introducing a ban on the use

of four phthalates (DEHP, DBP, DIBP and BBP) in consumer products this autumn. Once again,

Denmark is a first mover in the EU in banning dangerous chemicals. The Danish Consumer Council

and the Danish Ecological Council are very pleased with this development. The harmful effects of

the four chemicals have been known for many years, and the awareness of the danger is evidenced

by the fact that they are all on the ECHA candidate list and on track to be included on the

authorisation list [1]. It is definitely time for these substances to be removed from consumer

products.

In the draft version of the ban there are unfortunately a few exceptions, among these medical

devices, which do not fall under the Minister for the Environment’s portfolio. Therefore we

encourage you to do something about this.

It is unfortunate that medical devices such as implants, blood bags and catheters that are implanted

in humans and/or are in constant contact with the skin and mucous membranes are not covered by

the ban. The issue of phthalates in medical devices is not new. It has previously been discussed

whether the substances should be banned or restricted, but today there is still only a requirement

that medical devices which contain the four types of phthalates must be labelled. However, it does

not help the patients, as they do not get to see the package and therefore they cannot say no.

Today phthalates are permitted in products which are used for eg prematurely born babies. It is

problematic that the most vulnerable patients are exposed to harmful chemicals directly in the

bloodstream, where it is known that they may have endocrine disrupting effects. There are already

alternatives to phthalates for most medical devices [2], and these are even competitive in price. The

voluntary ability to use alternatives has not led to a phase-out of the harmful phthalates, and in

Denmark the PVC and phthalate taxes are not even required for medical devices that are CE

marked.

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A few hospitals are taking the lead and have phased out or are planning to phase out medical

devices containing phthalates. This is especially seen in hospital sections that take care of

prematurely born babies, because these patients are particularly vulnerable to endocrine disruptions

and need extra protection against harmful chemicals. At Sygehus Sønderjylland they have

catheters, IV sets, IV tubes, feeding tubes, gloves, pacifiers and bandages free of phthalates.

There is a first proposal for a revision of the Medical Devices Directive coming from the European

Commission this autumn, but the actual process of the review is likely to take much longer. And so

far there is no mention in the preliminary draft about the phthalate issue.

The Danish Consumer Council and the Danish Ecological Council believe that Denmark also in this

field should take the lead and work hard for a European ban on the four phthalates in medical

devices. There are already a number of alternatives to the four dangerous phthalates, which are used

in products where there is already a ban on certain phthalates, including toys. For a few product

groups there might not be alternatives. If so, the producers should document this, and if the

documentation is approved, then in these exceptional cases a temporary authorisation for use could

be granted while an alternative is developed.

While the revision is on-going in the EU, Denmark should ban the substances in medical devices on

the Danish market, just as the Minister for the Environment has for consumer products. If

swimming pools, shower curtains and tablecloths containing phthalates are harmful to humans, then

there is no doubt that tubes, catheters etc., which we put into the body, are as well.

We look forward to hearing your and the government’s opinion on this issue.

Yours sincerely

Rasmus Kjeldahl Christian Ege

Executive Director Head of Secretariat

The Danish Consumer Council The Danish Ecological Council

[1] http://echa.europa.eu/restrictions-under-consideration

[2] See a list of products that do not contain DEHP, DBP, BBP and DIBP - http://www.eco-

forum.dk/medicoartikler/Produktliste.pdf.