Extractables & Leachables (E&L) Testing for Product Safety and Quality

Ensuring the safety and quality of packaged goods and medical devices is paramount. Chemical substances can potentially migrate from packaging materials or device components into the products themselves. Understanding and quantifying this migration is the core of Extractables and Leachables (E&L) testing.

Understanding Extractables & Leachables

Chemical additives are commonly used to enhance the properties of materials used in packaging for beverages, food, and pharmaceuticals, as well as in medical devices. However, these additives have the potential to leach out of the material and into the product.

• Extractables Testing: This process identifies and measures potential chemicals that could migrate from a contact surface when exposed to adverse conditions. These conditions might include elevated temperatures, extended contact times, or aggressive solvents, representing a worst-case scenario.
• Leachables Testing: This focuses on identifying and quantifying the actual chemicals that migrate from a contact surface into the product under normal conditions of use and exposure.

Characterizing both extractables and leachables is an essential component of robust product quality control. It also serves as a critical validation step for raw material supplier qualification and their certification as “contaminant free.”

Our Comprehensive E&L Testing Approach

Eurofins Drinking Water Testing employs a simulated-use extraction methodology. This approach is based on established guidelines, including:

• U.S. Food and Drug Administration (FDA) 21 CFR 177
• ISO 10993-12 (2012)
• ISO 10993-18 (2005)

Our extraction process is meticulously designed to closely represent the routine conditions experienced during the packaging, transportation, and storage of beverages. We carefully control the ratio of the surface contact area to the extraction medium volume. This ensures that the testing conditions accurately mimic the real-world ratio of a beverage bottle's surface area to its volume, which is crucial for relevant and reliable results. We can also adjust exposure conditions to be more or less aggressive upon client request to meet specific testing needs.

This rigorous testing can be applied to various materials, including:

• Resin pellets
• Polymeric preforms
• Beverage bottles
• Caps and closures
• Other forms of packaging materials

Applications of Our E&L Testing

Our E&L testing services can be applied to a wide range of analytical methods to detect various potential migrants, including (but not limited to):

• Heavy Metals by EPA 200.8
• Phthalates by EPA 525.2
• Per- and Polyfluoroalkyl Substances (PFAS) by EPA 533 and 537.1
• Aldehydes by EPA 556
• Solvents by EPA 524.2
• Bisphenol A (BPA) by LC/MS/MS

Understanding Plastic Additives

Chemicals, known as plastic additives, are incorporated into polymers to enhance their properties, improve performance, extend lifespan, and facilitate easier processing. Common types of plastic additives include:

• Plasticizers: Increase softness, elasticity, and ease of molding.
• Flame Retardants: Slow or prevent the spread of flames and smoke.
• Stabilizers: Protect against degradation from molding temperatures, heat, UV exposure, and oxidation.
• Antioxidants: Prevent aging and oxidation of the plastic.
• Modifiers: Improve the impact resistance of plastics.
• Anti-Blocking Additives: Reduce friction between layers of plastic film.
• Blowing Agents: Create lightweight, shock-resistant, and heat-insulating foam plastics.
• Color Pigments: Provide consistent and specific uniform coloration.

Beverage Packaging Materials We Test

The manufacturing of beverage containers typically involves a two-stage process, allowing for a diverse range of bottle shapes and sizes:

1. Injection Molding: Raw resin pellets are first molded into preforms, which are preliminary shapes of beverage bottles with defined neck sizes.
2. Stretch Blow Molding: The preforms are then heated and stretched into the final shapes and sizes of beverage bottles.

These materials can include, but are not limited to:

• Polyethylene terephthalate (PET)
• Recycled polyethylene terephthalate (rPET)
• Polycarbonate (PC)
• Polyethylene (PE)
• Polypropylene (PP)
• Silicone

Why Choose Eurofins Environment Testing?

Eurofins Environment Testing is a global leader in drinking water and beverage testing, backed by 40 years of dedicated experience serving companies worldwide. Our commitment to excellence is demonstrated through:

• A world-class QA/QC system
• Recognized certifications, including TNI and ISO 17025
• Fast, reliable, and legally defensible results

We provide critical support for your quality program for beverages and beverage containers, helping you ensure product safety and regulatory compliance.