Regulatory compliance is an important consideration when selecting tubing materials for laboratory instrumentation, analytical systems, pharmaceutical applications, and regulated manufacturing environments. Many organizations require confirmation that components used in their equipment comply with the European Union Restriction of Hazardous Substances (RoHS) directives.

PTFE, PFA, and FEP tubing are widely used because of their exceptional chemical resistance, inertness, and suitability for high-purity applications. These fluoropolymer tubing materials are also compliant with current RoHS requirements.

RoHS Compliance Statement

PTFE (Polytetrafluoroethylene), PFA (Perfluoroalkoxy Alkane), and FEP (Fluorinated Ethylene Propylene) tubing products comply with:

• EU RoHS Directive 2011/65/EU (RoHS 2)
• EU Directive (EU) 2015/863 (RoHS 3 Amendment)

These regulations restrict the use of specified hazardous substances in electrical and electronic equipment and related components.

What Is RoHS?

The Restriction of Hazardous Substances (RoHS) legislation was established to reduce the use of materials that may present environmental or human health concerns.  The original directive restricted six substances. The RoHS 3 amendment expanded the list by adding four regulated phthalates.

Together, these directives help promote safer manufacturing practices and improved environmental stewardship.

Restricted Substances

PTFE, PFA, and FEP tubing products are manufactured without the ten restricted substances identified in Annex II of the RoHS Directive, including:

• Lead (Pb)
• Mercury (Hg)
• Cadmium (Cd)
• Hexavalent Chromium (Cr⁶⁺)
• Polybrominated Biphenyls (PBB)
• Polybrominated Diphenyl Ethers (PBDE)
• Bis(2-Ethylhexyl) Phthalate (DEHP)
• Benzyl Butyl Phthalate (BBP)
• Dibutyl Phthalate (DBP)
• Diisobutyl Phthalate (DIBP)

High-Purity Fluoropolymer Construction

PTFE, PFA, and FEP tubing are produced from high-purity fluoropolymer materials selected for demanding laboratory and industrial environments.  Benefits of these materials include:

• Excellent chemical inertness
• Broad solvent compatibility
• Thermal stability
• Low extractables
• High purity fluid transfer
• Resistance to corrosion

These characteristics contribute to their widespread use in analytical and process applications.

Regulatory Documentation

Supporting regulatory documentation may be available for:

• Supplier qualification programs
• Regulatory audits
• Quality assurance reviews
• Compliance verification activities

Common documentation may include:

• RoHS compliance declarations
• Material specifications
• Safety documentation
• Supporting product information

Typical Applications

RoHS-compliant PTFE, PFA, and FEP tubing are commonly used in:

• HPLC systems
• LC-MS systems
• Autosamplers
• Laboratory fluid transfer
• Pharmaceutical manufacturing
• Analytical instrumentation
• High-purity chemical handling
• Semiconductor applications

Their combination of purity and chemical resistance makes them suitable for demanding analytical environments.

Conclusion

PTFE, PFA, and FEP tubing products comply with RoHS 2 and RoHS 3 requirements and are manufactured from high-purity fluoropolymer materials that do not contain the ten restricted substances identified by the directive. Their chemical inertness, thermal stability, and low-extractable characteristics make them well suited for laboratory, analytical, pharmaceutical, and high-purity fluid handling applications