Brussels, 25 November 2014 – European manufacturers have requested an authorisation under the chemicals regulation REACH to continue using Bis(2-ethylhexyl) phthalate (commonly known as DEHP) in PVC in consumer products, including medical devices.
Aside from serious procedural issues associated with this authorisation dossier, HCWH is alarmed that approval of the authorisation would threaten the REACH objective of substitution of toxic chemicals. HCWH Europe calls on the European Commission to deny the request for authorisation to protect human health and the environment.
DEHP has been classified under the REACH regulation as a Substance of Very High Concern due to its toxicity, and is also suspected to be carcinogenic, neurotoxic and endocrine disrupting.
DEHP is a substance used as a plasticiser in PVC-based products, including medical devices such as tubing and catheters. DEHP can account for up to 40% of a final product, and can leach or transfer into body fluids, water and air. In women, elevated concentrations of DEHP and its main metabolite MEHP have been associated with premature births, premature breast development, and endometriosis in infertile women.
Medical devices can be an important source of exposure to DEHP in the health system, especially for vulnerable groups such as those with compromised immunity, pregnant women, and neonates. Safer alternatives to DEHP in PVC are widely available for medical devices.
The European Commission will make a decision on the authorisation request in early 2015. To put pressure on the Commission to consider the procedural issues and the health concerns, HCWH Europe, along with its members Ecobaby Foundation, Arnika Association, Helse Sør-Øst RHF, Bund, the Jegrelius Institute for Applied Green Chemistry, and the British Society for Ecological Medicine and 48 other organisations have released a joint letter asking that the Commission deny the authorisation request.
"This authorisation must be denied to respect REACH principles and procedures, and especially to protect human health and environment," Chemicals and Pharmaceuticals Policy Officer Laurel Berzanskis stated. "It’s unacceptable that medical devices designed to help heal can actually be toxic."
Find out more about our work on safer chemicals:
- Safer Medical Devices Database
- Factsheet on Hazardous Chemicals in Medical Devices: Phthalates
- Leaflet on EDCs for Health Professionals (available in English, French, German, Hungarian, Italian and Spanish)
- Webinar on Endocrine Disruptors in Healthcare
Media: Rosalind Simpson, Communications and Press Officer, HCWH Europe
E. firstname.lastname@example.org T. +32 2503 4911
 Meeker et al., 2009, Urinary phthalate metabolites in relation to preterm births in Mexico City, Environ Health Perspect 117: 1587-1592.
 Colon et al., 2000, Identification of phthalate esters in the serum of young Puerto Rican girls with premature breast development. Environ Health Perspect 108: 895-900.
 Reddy et al., 2006, Association of phthalate esters with endometriosis in Indian Women, Int J Obstet Gyn 113: 515-520.