DEHP phthalates in medical devices - GOV.UK

                                               
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Diethylhexyl phthalate - GreenFacts

                                               
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6. Does DEHP pose risks to human health? - GreenFacts

                                               
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Bis(2-ethylhexyl) phthalate

                                               
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Di(2-Ethylhexyl)Phthalate (DEHP) | ToxFAQs | ATSDR

                                               
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  • What is DEHP/DOP used for?
  • It is a broad-spectrum plasticizer used mostly to render polyvinyl chloride products soft, pliable, and durable. DEHP/DOP is the most widely used plasticizer in the manufacture of many vinyl products, including disposable gloves. Q: Why is there increased interest in DEHP/DOP?
  • Is DEHP carcinogenic to humans?
  • IARC has concluded that DEHP is possibly carcinogenic to humans (Group 2B). In 1988, JECFA evaluated DEHP and recommended that human exposure to this compound in food be reduced to the lowest level attainable. JECFA considered that this might be achieved by using alternative plasticizers or alternatives to plastic material containing DEHP.
  • Is DEHP still necessary in medical devices?
  • The Medical Device Regulations (SI 2002 No 618, as amended) (UK MDR 2002) require any materials presenting a hazard to be replaced as soon as alternatives with a more positive risk-to-benefit balance are available. It seems that DEHP may still be essential in some medical devices in critical circumstances.
  • What are the Occupational Standards for DEHP?
  • Occupational standards for DEHP WEL = workplace exposure limit. LTEL = long-term exposure limit. STEL = short-term exposure limit. Health and Safety Executive (HSE). ‘EH40/2005 Workplace Exposure Limits . Fourth Edition’ 2020. (viewed on 117 January 2025) Table 7. Public health standards and guidelines World Health Organisation.
  • Is Deha present in drinking water?
  • Reports of the presence of DEHA in surface water and drinking-water are scarce, but DEHA has occasionally been identified in drinking-water at levels of a few micrograms per litre. As a consequence of its use in PVC films, food is the most important source of human exposure (up to 20 mg/day).