BioFlex®
The original medical-grade flexible body jewelry — certified to ISO 10993-6 and built on a USP Class VI biocompatible resin before any regulator required it. Not TPU. Not urethane. Not acrylic.
Created by Patrick Poli
BioFlex® was developed at Europierce Worldwide Ltd in the United Kingdom in the late 1990s. More than a year of injection trials, mould development, and formulation testing went into the material before it was considered ready. It was certified to ISO 10993-6 and built on a USP Class VI biocompatible resin before any regulator required it — not to meet a standard, but because it was the right thing to do.
BioFlex® is a medical-grade random copolymer in the PP-R class. It is not TPU. It is not thermoplastic urethane. It is not acrylic, PMMA, nylon, or PVC. It shares none of their toxicological profiles and none of their regulatory problems. The confusion in the market — and in some regulatory frameworks — stems from cheap uncertified copies being sold under the same name, not from any failing of the genuine material.
Patrick Poli is the creator of BioFlex® and Director of Poli International Co., Ltd (formerly Europierce Worldwide Ltd, UK). The full story — including the counterfeit problem, the APP's silence, and why the "post-operative use only" label is a category error — is set out in the article below.
Chemistry at a Glance
Compliance Credentials
Live SVHC Monitoring
BioFlex® compliance is actively maintained. Our automated monitoring checks the ECHA SVHC Candidate List every 14 days and flags any substance relevant to PP-R polymer chemistry.
Official Documentation Downloads
Signed originals with company stamp — available to trade professionals, studio owners, and regulatory bodies. Open in your browser to read, or download for your compliance records.
Official signed declaration under REACH Article 33. Confirms no substance of very high concern exceeds 0.1 % w/w in BioFlex® articles.
Full compliance datasheet: material class, certifications, phthalate screening results, REACH status, and ISO 10993-6 references. Signed original with company stamp.
BioFlex® Is Not What the Internet Thinks
A detailed 3,000-word article by Patrick Poli addressing every misconception — the chemistry, the counterfeits, the regulatory category errors, and 25 years of the APP's silence.
Read the Full Article →BioFlex® in Practice
Seven cases where the material choice is not cosmetic — it is the difference between a healed piercing and a damaged one. Written by the inventor of BioFlex®.
Frequently Asked Questions
Is BioFlex® the same as TPU or thermoplastic urethane?
No. BioFlex® is a medical-grade random copolymer in the PP-R class. It is not TPU, not thermoplastic urethane, and not acrylic, PMMA, nylon, or PVC. It shares none of their toxicological profiles. The confusion in the market comes from cheap uncertified copies sold under the same name, not from the genuine material.
Is BioFlex® SVHC-free under REACH?
Yes. Every substance in BioFlex® sits below 1 ppm, three orders of magnitude under the 1,000 ppm REACH threshold, so nothing exceeds the 0.1% disclosure obligation in ECHA Article 33. A signed SVHC-free declaration is available to trade professionals.
Can BioFlex® be autoclaved?
Yes. BioFlex® is autoclave-stable for 8 to 12 cycles before any degradation begins.
Does BioFlex® contain nickel?
No. BioFlex® has zero nickel content, which removes the most common cause of body-jewelry contact allergy.
Is BioFlex® safe to wear during an MRI?
Where every major MRI safety protocol requires metal jewelry to be removed before scanning, BioFlex® PP-R is non-ferromagnetic, non-conductive, and fully radiolucent, so it passes the scanner without removal.
Who created BioFlex®, and when?
BioFlex® was developed by Patrick Poli at Europierce Worldwide Ltd in the United Kingdom in the late 1990s, after more than a year of injection trials, mould development, and formulation testing. It now has over 25 years of clean real-world use.
Which certifications does BioFlex® hold?
BioFlex® is certified to ISO 10993-6 for biological evaluation of implantable materials and is built on a USP Class VI biocompatible resin, the highest USP plastics biocompatibility class. It is REACH SVHC-free and carries no ECHA Article 33 disclosure obligation.
Trade Enquiries & Documentation Requests
For SVHC-free declarations, compliance datasheets, wholesale enquiries, or to discuss BioFlex® certification with Patrick directly:
Contact Patrick Poli →