Standard
REACH & SVHC Declaration
Statement against the current ECHA Candidate List, refreshed when the list updates. Covers virgin and filled fluoropolymer grades.
About · Compliance
Compliance — REACH, RoHS, FDA & Beyond
Procurement and QA teams want to know one thing: will this lot clear our compliance gate without a hold? Every shipment from Peflon arrives with the documents your regulatory file needs — REACH and SVHC declarations, RoHS 3, PFOA / PFOS-free statements, halogen-free statements, FDA 21 CFR 177.1550 references for virgin grades, USP Class VI on request, plus a CoA keyed to the lot you actually received.
4 Stages
IQC · In-Process · Final · Outgoing
10+
Analytical Methods per Lot
100%
Lot Traceability
24 h
Standard Doc Turnaround
Buyer Personas
Who Needs Which Document
Compliance is a procurement question and an engineering question at the same time. The four roles below are the ones we hear from most — and the documents each one actually puts in their file.
QA & Regulatory
REACH / SVHC, RoHS 3, FDA, USP, halogen-free, PFOA / PFOS-free statements — issued at the lot or grade level for the audit file.
Procurement
CoA per shipment, SDS, TDS, customs paperwork (HS / CN code, country of origin), supplier-quality records.
OEM Auditors / Customers
Supply-chain traceability, ISO-aligned process control, lab method list, batch CoA against the relevant ASTM / ISO method.
Distributors
Master declarations covering the SKU range you stock — REACH, RoHS, PFOA-free — refreshed annually for resell documentation.
Coverage
What We Cover
Standard coverage shipped with every relevant material lot. Items marked on request are issued for the specific grade and lot once we confirm scope with you.
Standard
RoHS 3 (EU 2015/863)
Declaration covering all 10 restricted substances, including the four phthalates added in 2015 — referenced against EN IEC 63000 test methods.
Standard
PFOA / PFOS / PFAS-Aid Statement
Peflon abandons traditional perfluorooctanoate processing aids — virgin PTFE, PFA, FEP, ETFE and PVDF resins ship as PFOA-free and PFOS-free, aligned with EU REACH Annex XVII restrictions.
Standard
Halogen-Free (Cl, Br) Statement
Cable and wire grades pass IEC 61249-2-21 thresholds — <900 ppm Cl, <900 ppm Br, <1500 ppm total halogens — supporting halogen-free electronics builds.
On Request
FDA 21 CFR 177.1550
Food-contact compliance reference for virgin PTFE, FEP and PFA grades intended for repeated-use food-contact articles. Issued per qualifying grade.
On Request
USP Class VI Biocompatibility
Available for virgin PTFE, PFA and FEP grades supplied to medical-device, pharma and life-science fabricators. Test report issued against USP <88>.
On Request
UL94 Flame Rating
Most virgin fluoropolymer grades meet UL94 V-0 by composition. Test reference and supplier flammability statement supplied for cable, electronics and battery-pack applications.
On Request
SEMI F-57 (Semiconductor PFA)
High-purity PFA grades aligned with SEMI F-57 purity targets for fluid-handling components in semiconductor processing.
On Request
IATF 16949-Aligned Automotive Lots
For PPAP-style programs, share your APQP package and we'll quote a qualified-lot tier with the documentation an IATF audit expects.
Coverage Matrix
Material × Compliance Matrix
The standard coverage by material family. Filled and modified grades carry the same coverage as the base resin unless the filler triggers a separate declaration (e.g. metal-filled grades for RoHS lead screening). Confirm the exact grade in your inquiry.
| Material | REACH / SVHC | RoHS 3 | PFOA / PFOS-Free | Halogen-Free | FDA 21 CFR 177.1550 | USP Class VI | UL94 |
|---|---|---|---|---|---|---|---|
| Virgin PTFE | ✓ | ✓ | ✓ | ✓ | ✓ on virgin grades | On request | V-0 |
| Modified PTFE | ✓ | ✓ | ✓ | ✓ | On request | On request | V-0 |
| Filled PTFE (glass / carbon / graphite) | ✓ | ✓ | ✓ | Filler-dependent | Filler-dependent | Rarely | V-0 |
| PFA | ✓ | ✓ | ✓ | ✓ | ✓ on virgin grades | On request | V-0 |
| FEP | ✓ | ✓ | ✓ | ✓ | ✓ on virgin grades | On request | V-0 |
| ETFE | ✓ | ✓ | ✓ | ✓ | Grade-dependent | On request | V-0 |
| PVDF | ✓ | ✓ | ✓ | ✓ | Grade-dependent | On request | V-0 |
| PCTFE | ✓ | ✓ | ✓ | ✓ | Grade-dependent | n/a | V-0 |
| PEEK | ✓ | ✓ | n/a (not a fluoropolymer) | ✓ | ✓ on virgin grades | Available | V-0 |
For mixed-grade orders (e.g. virgin PFA plus bronze-filled PTFE), declarations are issued per grade so your QA file stays clean line-by-line. We do not write a blanket "all materials covered" letter without backing test data.
Standard Lot Bundle
What Ships With Every Lot
Standard documents bundled with every shipment — no extra charge, no extra request needed. Specialty documents follow the request flow below.
Documentation Bundle
- Certificate of Analysis (CoA) keyed to the lot ID
- Safety Data Sheet (SDS) — current revision, customer language
- Technical Data Sheet (TDS) — grade-specific properties
- REACH / SVHC declaration referencing the active Candidate List
- RoHS 3 declaration (EU 2015/863)
Shipping & Customs Bundle
- PFOA / PFOS / PFAS processing-aid statement
- Halogen-free statement (cable / electronics grades)
- Customs paperwork — HS code, CN code, country of origin
- Packing list with net / gross weight per pallet
- Photographs of the actual pallet on request before shipment
Request Flow
How to Request Specific Documents
For FDA, USP Class VI, UL94, IATF, SEMI F-57 or any program-specific declaration, follow the three steps below. We turn most document requests around in one working day.
-
Tell Us the Grade and the Use
Material (e.g. virgin PFA), form (resin / dispersion / rod), end use (food contact, medical device, automotive, semicon). The use determines which standard applies.
-
Confirm Document Scope
Lot-specific or grade-blanket? Customer-letterhead format or our standard? We'll quote any required third-party testing up front, before issuing.
-
Receive Document With the Shipment
Standard documents travel with the goods. Lot-specific declarations and test reports are emailed to your QA contact in PDF and archived against the lot ID for re-issue.
Quality Control
Quality Control Behind the Documents
A declaration is only as good as the testing behind it. Peflon runs 10+ analytical methods across 4 QC stages on every batch — IQC, in-process, final and outgoing — with 100% lot traceability. The matrix below is a snapshot of the lab.
ICP-MS
Trace metallic ions for SEMI / UHP grades.
FTIR
Functional group ID, lot-to-lot consistency.
DSC
Melt point, crystallinity, thermal history.
MFR / MFI
Melt flow for FEP, PFA, ETFE extrusion.
Full instrumentation list, lab walk-through and analytical method documentation: see facilities and laboratories.
Standards & References
Standards & References
The regulatory and standards bodies behind the declarations. We cite the original instrument — not a competitor — so your auditor can verify the source.
ECHA — REACH & SVHC
European Chemicals Agency. Holds the current Candidate List of Substances of Very High Concern (SVHC) and the REACH Annex XVII restriction list. Our declarations are dated against the active list version.
US FDA — 21 CFR 177.1550
US food-contact rule for perfluorocarbon resins (PTFE, FEP, PFA) intended for repeated-use food-contact articles. We reference the current eCFR text and supply test data on request.
EU RoHS Directive (2011/65/EU + 2015/863)
EU restriction on hazardous substances in electrical and electronic equipment, including the four phthalates added in 2015. Our RoHS 3 statement covers all 10 restricted substances.
FAQ
FAQ — What Procurement & QA Ask Us Most
Are Peflon fluoropolymers really PFOA-free and PFAS-free?
Two layers to that question. (1) Processing aids: our virgin PTFE, FEP, PFA, ETFE and PVDF are produced without traditional perfluorooctanoate (PFOA) or PFOS surfactants — these residual processing aids are below detection in our finished resin. (2) Polymer backbone: fluoropolymers like PTFE are themselves classified as polymeric PFAS and contain fluorine in the chain — that's by design, and what gives the family its chemical resistance. EU REACH and the OECD treat fluoropolymers of low concern (PLC) separately from non-polymeric PFAS surfactants. We can issue a statement covering both layers for your audit.
Will the CoA reference the actual lot I receive, or a generic specification?
The actual lot. Each CoA carries the lot ID, production date and the measured values from that lot — MFR / MFI, melt point, particle size or apparent density depending on the grade. The lot ID also appears on the carton and pallet, so your incoming QC can match physical goods to the CoA without ambiguity.
How fast can you turn around an FDA or USP Class VI declaration?
For grades that already qualify, the declaration is issued within one working day — we keep the underlying test reports on file. If your end use needs a fresh extraction or biocompatibility study (e.g. a new device class), allow 4–8 weeks for the third-party lab cycle. We quote the test cost up front before starting.
Can you supply documents on our letterhead format?
Yes — we routinely match enterprise procurement templates. Send the form (PDF or editable). For declarations cited in regulatory filings, we usually recommend our standard format for traceability, with your reference fields embedded.
For an automotive program, how do you align with IATF 16949?
We supply commercial-grade fluoropolymer with full CoA per shipment as standard. For programs that require IATF-aligned process control and PPAP-style documentation, share your APQP package and we'll quote against it as a separate qualified-lot tier with the document set an IATF audit expects.
For semiconductor PFA, what does "SEMI F-57" really mean from your side?
SEMI F-57 sets purity targets for polymer fluid-handling components — total organic carbon, metallic ions per element, particle counts. We supply PFA grades aligned with those targets and CoA against the relevant ICP-MS metallic-ion list. Share your fab's specific limit table and we'll match the grade.
What about CBAM, customs and country-of-origin paperwork?
Each shipment carries the HS / CN code, country of origin and net / gross weight on the packing list and commercial invoice. For EU customers under CBAM, we provide the documentation needed for declarant filings. Share your importer reference and we'll structure the paperwork accordingly.
Is the documentation set the same whether I order 25 kg or a full container?
Yes. The standard document bundle ships with every order regardless of size. For repeat distributors and OEM customers, we can also issue an annual master declaration covering your full SKU range to cut paperwork on individual purchase orders.
Specific Declaration Needed?
Need a Specific Declaration Before You Order?
Tell us the grade, the end use and the document — REACH, RoHS, FDA, USP Class VI, UL94, halogen-free, IATF, SEMI F-57. We'll come back with the document scope, any test cost, and lead time within one working day.