Endocrine Disruptor Leaching Issues from Vinyl Chloride Products - 2001-2020s History

Endocrine Disruptor Leaching Issues from Vinyl Chloride Products - 2001-2020s History

2001: The Problem Revealed
In 2001, the human health effects of diethylhexyl phthalate (DEHP), which leaches from PVC products, especially from IV tubes and infusion bags used for medical purposes, became an issue. DEHP is widely used as a plasticizer and has a flexibility-enhancing effect. Concerned about serious risks, especially for people requiring long-term intravenous infusion, such as newborns and chronically ill patients, the Ministry of Health, Labor and Welfare (MHLW) initiated an investigation.

Medical device manufacturers promoted research into alternative materials such as polyethylene and polypropylene that do not use DEHP. The European Union (EU) introduced regulations restricting the use of DEHP in the early 2000s, and a worldwide response began. In Japan, too, the proper use of products and training for medical professionals were promoted, and awareness of the effects of vinyl chloride products on the human body increased.

2010s: Tighter Regulations and Technological Innovation
In the 2010s, the EU's REACH regulation designated DEHP as a substance of very high concern (SVHC) and severely restricted its use. Meanwhile, in the U.S., the state of California tightened regulations based on Proposition 65, which strictly controlled DEHP content in consumer products.

In the medical field, companies such as Sumitomo Chemical and BASF worked to develop safe alternatives. The non-phthalate plasticizer Hexamoll® DINCH and biomass-derived polyethylene products were developed to improve the safety of medical products. These efforts were particularly successful in Europe and the United States, where progress was made in reducing the use of DEHP.

2020s: Sustainable Initiatives and Challenges
In the 2020s, as the reduction of PVC products progressed, there were disparities in progress by region. Children's Hospital in Boston fully implemented DEHP-free IV tubing, reducing leachables by more than 90%. The University Hospital of Heidelberg also made progress in introducing polypropylene alternatives. However, developing countries have been slow to adopt regulations and technologies, making international cooperation a challenge.

Sumitomo Chemical has introduced biomass-derived medical products to the market, achieving the goal of 20% of the global market by 2023. BASF has increased its production capacity of non-phthalate plasticizers by 30%. While this has helped to reduce health risks, increasing costs for medical institutions have emerged as a challenge.

Conclusions and Outlook
From 2001 to the 2020s, the problem of endocrine disruptor leaching from PVC products has made progress due to stricter regulations and technological innovations. While alternative products are becoming more widely used in developed countries, developing countries are facing a slow response. In the future, we need to strengthen safe product supply and international cooperation to achieve sustainable solutions for both the environment and the human body.