France’s Important Move Towards Phasing Out Phthalates in Medical Devices

Brussels — Today France passed a law that for the first time bans the use of tubes containing di-(2-ethylhexyl) phthalate (DEHP) in paediatrics, neonatology and maternity wards in hospitals.

The ban will come into effect on 1st July 2015, but the law also foresees the possibility, in the near future, to prohibit the use of three phthalates: di (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and butyl benzyl phthalate (BBP) in all medical devices if alternative materials are available and the safety of the device is guaranteed. This is an important first step towards the phase out of phthalates in all medical devices in Europe. At the time when the European Parliament and Council are getting ready to debate new European Commission’s (EC) proposals (1) that revise the Medical Device Directives, the French ban will put strong pressure on the European institutions to do the same. The current EC proposal for a Regulation on Medical Devices only requires that phthalates are labelled, either on the sales package or on the device itself, meaning that health professionals and patients might not be aware that devices used for treating diseases contain phthalates.

Phthalates are chemicals used to soften PVC. Therefore, they are abundant in PVC- based medical devices such as blood bags, intravenous bags, tubes, catheters and disposable gloves, primarily in the form of the phthalate di-(2-ethylhexyl)phthalate (DEHP). There are strong indications that phthalates are endocrine disruptors (EDs), and EDs in general interfere with the hormone systems of living creatures, which is potentially very damaging, as our hormones control many biological functions, including reproduction and metabolism. Endocrine disrupting chemicals (EDCs) have been increasingly linked to a range of health problems including altered brain development, giving rise to behavioural, cognitive or attention deficit disorders (2, 3), cancers (particularly breast, prostate and testicular cancer) (4, 5), diabetes (6), reproductive disorders (7), and impaired fertility (8) in wildlife and in humans (9).

As phthalates may leak from the PVC-based device directly into the human body, scientific studies have found phthalate metabolites in the urine of neonates in intensive units. Phthalates and their metabolites are found in general in urine, blood, naval cord blood, semen, breast milk, placental tissue and amniotic fluid. Currently there are on the market many alternative products available to substitute the phthalate containing medical devices and various listings have been made by for example the Danish EPA (10) and HCWH (11).

Grazia Cioci, Policy Director of HCWH Europe states: Health Care Without Harm Europe now calls on all European Member States to follow the example of France and move towards a phase out of phthalates in medical devices as swiftly as possible. HCWH Europe also calls on the European institutions to be more ambitious in the new legislative proposals on medical devices by requiring the phasing out of EDCs and phthalates in medical devices, as it is already the case in toys and baby products in Europe, and pushing for mandatory PVC-free medical devices, unless no substitutes are available for specific uses.

Notes:

• On 26 September 2012, the European Commission adopted a package on innovation in health consisting of
  1. Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals;
  2. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/20092;
  3. Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices.
• Ishido et al., 2007, Mesencephalic neurodegeneration in the orally administered bisphenol A-caused hyperactive rats. Toxicol Lett., 173:66–72
• Jurewicz and Hanke, 2011, Exposure to phthalates: Reproductive outcome and children health. A review of epidemiological studies. International Journal of Occupational Medicine and Environmental Health, 24:115-141
• Soto and Sonnenschein, 2010, Environmental causes of cancer: endocrine disruptors as carcinogens. Endocrinology, 6:363-370
• Jenkins et al., 2007, Prenatal TCDD exposure predisposes for mammary cancer in rats. Reprod. Toxicol., 23:391-396
• Lim et al., 2008, Association of Brominated Flame Retardants with Diabetes and Metabolic Syndrome in the U.S. Population, 2003–2004. Diabetes Care, 31:1802–1807
• Markey et al., 2005, Long-term effects of fetal exposure to low doses of the xenoestrogen bisphenol-A in the female mouse genital tract. Biol Reprod. 72:1344-1351
• Cohn et al., 2003, DDT and DDE exposure in mothers and time to pregnancy in daughters. Lancet, 361:2205-2206
• Damstra et al., 2002, Global Assessment of the State-of-the Science of Endocrine Disrupters. WHO/I PCS/EDC/02.2. World Health Organization/International Programme on Chemical Safety, Geneva
• http://www.eco-forum.dk/medicoartikler/Produktliste.pdf
• http://www.noharm.org/lib/downloads/pvc/PVC_Alternatives_Europe.pdf

Health Care Without Harm is an international coalition of more than 500 organizations in 53 countries, working to transform the health care sector worldwide, without compromising patient safety or care, so that it is ecologically sustainable and no longer a source of harm to public health and the environment. Visit the HCWH website for more information.