Phthalates in medical devices: regulations and alternatives

Since the early 2000s, particularly in Europe, there has been a growing awareness of the impact of chemical substances on the environment and human health, including their long-term or unknown effects. The SCENIHR 2008 report flagged risks such as endocrine disruption and reproductive toxicity, especially in vulnerable populations. Its 2015 update reinforced these findings and emphasized on safer alternatives. The SCHEER report expanded on environmental impacts and lifecycle risks, advocating for regulatory action.

To ensure a high level of protection for human health and the environment, the European Union (EU) adopted the Registration, Evaluation, Authorization, and Restriction of Chemicals Regulation (Regulation (EC) 1907/2006 – REACH) in 2006, which came into force in 2007 with the establishment of the European Chemicals Agency (ECHA). REACH applies to all chemical substances and affects most companies across the EU, including those importing chemicals for food containers, toys, medical devices, and other consumer goods. Additionally, REACH aims to foster innovation and competitiveness by evaluating safer alternatives, promoting non-animal testing, and bringing together expert groups.

This newsletter focuses on phthalates such as di-(2-ethylhexyl) phthalate (DEHP). These chemicals are used as plasticizers to soften and increase the flexibility of plastics, particularly polyvinyl chloride (PVC). DEHP and other phthalates are on the REACH list of Substances of Very High Concern (SVHC).

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