Phthalate-free X-ray detectable yarn

Did you know? SFM’s X-ray detectable yarn is free from phthalates.

SFM is proud to state that no phthalates are used in any of its product offerings. As we take the safety of our products end user very seriously. One of our long standing products has been the polypropylene-based phthalate-free X-ray detectable yarn used in the manufacture of X-ray detectable gauze, swabs and sponges using both woven and non-woven fabrics.

In the light of the current health concerns around phthalates, the key feature of our X-ray detectable yarn is that it is phthalate-free unlike the PVC alternative used by many. The yarn is melt spun from approximately 40 PP filaments with a high loading of barium sulphate (60%) which are wrapped with a fine polyester thread. It is this multi-filament composition that confers the thread its flexibility and softness, without the need to add plasticisers such as phthalates to the manufacturing process.

We can manufacture the X-ray detectable yarn in a range of linear densities to suit customer requirements, so please do not hesitate to contact us for any additional information. Our expert team is more than happy to answer any questions you might have about our phthalate-free X-ray detectable yarn or to send samples upon request.

What are phthalates?

Phthalate esters or simply phthalates are chemicals used to confer plastic, mainly polyvinyl chloride (PVC), more flexibility, durability and transparency. This is why they are also called plasticisers.

The most common phthalates are di(2-ethylhexyl) phthalate (DEHP), diisodecyl phthalate(DIDP), and diisononyl phthalate (DINP). Each year, about 8.4 million tonnes of plasticisers are manufactured globally, with Europe accounting for approximately 1.5 million tonnes.

Phthalates are used on a large scale to manufacture anything from building materials, detergents, textiles, children’s toys, food products & food containers to personal-care items such as perfume, hair spray or nail polish, pharmaceuticals and medical devices, to name just a few.

Is there legislation regulating the use of phthalates in medical devices?

Several countries and states have adopted specific legislation to regulate the use of phthalates in a number of products, such as children’s toys (US Consumer Product Safety Improvement Act 2008) and ingredients in cosmetics (Directive 2005/90/EC).

  • Proposition 65

Proposition 65 is a piece of legislation passed by Californians in 1986 requiring the Californian state to publish a list of chemicals at risk to cause birth defects, reproductive harm or cancer. Under Proposition 65, businesses operating in California are under the obligation to provide warnings to consumers about any products which contain any such chemicals.

Di(2-ethylhexyl) phthalate (DEHP) was included on this list in 1988, and under the Californian law, the manufacture, sale or distribution of children’s toys and childcare articles containing DEHP, DBP or BBP in a ratio higher than 0.1% is prohibited.

  • Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices

The EU has also been taking a stance against the use of phthalates in certain medical devices, by launching a Public consultation on the Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices. The deadline for submitting comments on the Preliminary Guidelines was 29th April, 2019, and a final opinion will then be formulated based on these contributions.

References

  1. https://www.p65warnings.ca.gov/fact-sheets/phthalates
  2. https://www.chemsafetypro.com/Topics/EU/REACH_annex_XVII_phthalates_restriction.html
  3. https://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scheer_consultation_08_en
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3550149/
  5. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/limiting-use-certain-phthalates-excipients-cder-regulated-products
  6. https://www.gov.uk/government/publications/dehp-phthalates-in-medical-devices/dehp-phthalates-in-medical-devices
  7. https://www.medica-tradefair.com/cgi-bin/md_medica/lib/pub/tt.cgi/Final_opinion_on_the_safety_of_medical_devices_containing_DEHP_phthalate.html?oid=55532&lang=2&ticket=g_u_e_s_t
  8. https://www.theguardian.com/us-news/2019/may/23/phthalates-everyday-products-toxics-guide
  9. https://www.sgs.com/en/news/2019/05/safeguards-06919-california-proposition-65-reformulation-of-dehp-in-consumer-products?dc=http&lb=
  10. https://www.p65warnings.ca.gov/about/frequently-asked-questions