BioFlex®

The Original. Certified. 25 Years of Clean Performance.

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 FDA Class IV 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 in the article below.

Chemistry at a Glance

Material class
PP-R random copolymer (medical grade)
NOT
TPU · urethane · acrylic · PMMA · nylon · PVC
Phthalate traces
<1 ppm (REACH threshold: 1,000 ppm)
Nickel content
Zero
Autoclave stable
8–12 cycles before any degradation begins
In use since
Late 1990s — over 25 years of clean real-world data

Compliance Credentials

ISO 10993-6
Biological evaluation of implantable materials
FDA Class IV
Pre-market clearance for medical-grade polymers
REACH SVHC-Free
All substances below 1 ppm — three orders below threshold
ECHA Article 33
No SVHC disclosure obligation — nothing exceeds 0.1%

Documentation Downloads

The following documents are available to trade professionals, studio owners, and regulatory bodies. Signed originals with company stamp are being prepared — check back shortly or contact us directly to request a copy by email.

📄 SVHC-Free Declaration

Official declaration under REACH Article 33. Confirms no substance of very high concern exceeds 0.1% w/w in BioFlex® articles.

Signed copy coming soon
📄 BioFlex® Compliance Data Sheet

Full compliance datasheet: material class, certifications, phthalate screening results, REACH status, and ISO 10993-6 references.

Signed copy coming soon

The Full Correction

Patrick Poli has written a detailed, 3,000-word article addressing every misconception about BioFlex® — the chemistry, the counterfeits, the regulatory failures, and the APP's 25 years of silence. It is published in the Body Art News journal.

Read: BioFlex® Is Not What the Internet Thinks →

Trade Enquiries & Documentation Requests

For SVHC-free declarations, compliance datasheets, wholesale enquiries, or to discuss BioFlex® certification with Patrick directly:

Contact Patrick Poli →