Recently, the European Union updated its recommendations and benefit-risk assessment guidelines for the use of phthalates, particularly DEHP, in medical devices. This update reflects the EU's ongoing commitment to public health and environmental safety. The goal is to ensure the safety of medical devices, reduce potential health risks, and promote sustainable industry practices.
Compared to the previous guidelines released in 2019, the latest version includes the following updates
1. Deadline for DEHP Use: The deadline for the continued use of DEHP in medical devices is set for July 1, 2030. After this date, to use DEHP, justification under MDR regulations and REACH (Regulation (EC) 1907/2006) authorization will be required.
2. Evaluation of Non-Phthalate Alternatives: To avoid unnecessary evaluations of numerous alternatives, the new guidelines require assessing at least three alternatives. If fewer than three alternatives are evaluated, additional information must be provided to justify this.
3. Current Exposure to Phthalate Alternatives: The guidelines include an assessment of the current use and potential exposure pathways of phthalate alternatives in medical devices. It discusses the migration/leakage characteristics of these alternatives and how these properties affect patient and user exposure risks. Key factors such as chemical structure, physicochemical affinity, vapor pressure, and molecular weight must be considered.
4. Toxicological Information on Phthalate Alternatives: The guidelines provide toxicological information on phthalate alternatives, discussing key endpoints such as carcinogenicity, mutagenicity, and reproductive toxicity. Based on these endpoints, a No Observed Adverse Effect Level (NOAEL) or Lowest Observed Adverse Effect Level (LOAEL) is provided.
5. Performance Data on Alternatives to DEHP: DEHP has long been the preferred material for blood bag sets used for collecting, processing, and storing red blood cell concentrates. It facilitates centrifugation, sealing, transportation, and general handling without the risk of breakage or product loss. DEHP leaches into red blood cell membranes and stabilizes them, maintaining cell integrity and reducing hemolysis, thus extending the storage time of red blood cell concentrates. Appendix 10 provides performance data on alternatives (such as DINCH, DEHT, BTHC, DOTH, and DL9TH) in maintaining red cell integrity, reducing hemolysis, and extending storage periods. However, it emphasizes the need for comprehensive benefit-risk assessments before replacing DEHP to ensure that alternatives do not compromise red cell storage capacity.
What are Phthalates?
Phthalates, also known as phthalate esters, are important organic compounds widely used as plasticizers in polyvinyl chloride (PVC) materials, making hard plastics flexible. They are commonly found in toys, food packaging materials, medical blood bags and tubes, vinyl flooring, and wallpaper.
Hazards of Phthalates
- Male Reproductive System Toxicity: Phthalates exhibit testicular toxicity, causing severe testicular atrophy, significant changes in testosterone levels, reduced spermatocytes, rapid decline in testicular marker enzyme activity, and reduced sperm count.
- Female Reproductive System Toxicity: Phthalates are toxic to the uterus and ovaries, potentially leading to prolonged estrous cycles, decreased progesterone levels, increased uterine weight, altered natural ovulation cycles, and delayed or anovulatory cycles.
- Impact on Blood System: Phthalates significantly reduce hematocrit levels, decrease hemoglobin content, and increase platelet adhesion.
- Teratogenicity: Studies show that exposure to low doses of phthalates increases the probability of fetal death and causes acute cardiac, renal, and pulmonary toxicity, leading to death.
- Liver Toxicity: Phthalates cause oxidative damage to proteins, liver cell membrane lipids, and DNA, potentially damaging stem cells.
- Carcinogenicity: Long-term exposure to phthalates significantly increases the risk of malignant stem cell tumors.
All our products (J388 series, JDCH888 series, JDCH999 series) are non-phthalate, eco-friendly plasticizers that do not contain DEHP, BBP, DBP, DIBP, DINP, DIDP, or DNOP. They have passed relevant SGS RoHS testing and certification. For detailed product testing information, please scan the QR code below.
