Phthalates Testing & Analysis

Phthalates are a group of synthetic chemical compounds primarily used as plasticizers to increase flexibility and durability in plastics, particularly polyvinyl chloride (PVC). They are not chemically bound to the material and can leach into food, water, or the environment. As endocrine-disrupting compounds, their presence in food—especially fatty or packaged foods has become a growing concern for food safety regulators, manufacturers, and consumers.

What Are Phthalates?

Common phthalates of concern in food contact and packaging materials include:

• DEHP (Di(2-ethylhexyl) phthalate)
• DBP (Dibutyl phthalate)
• DINP (Diisononyl phthalate)
• DIDP (Diisodecyl phthalate)
• BBP (Butyl benzyl phthalate)

These compounds can migrate into food products from:

• Plastic processing equipment
• Flexible PVC tubing or packaging
• Food handling gloves
• Conveyor belts
• Printing inks or coatings

Concerns in the Food Industry and Food Products

Phthalates present several challenges for food manufacturers and product developers:

• Migration from Packaging Materials: Phthalates can leach from flexible plastics, PVC coatings, and adhesives into food—especially fatty and high-temperature-processed items.
• Contamination during Processing: Transfer from tubing, conveyor belts, and gloves during food handling and packaging operations.
• Regulatory Non-compliance: Inconsistent sourcing or oversight can result in violations of migration limits, particularly in exported goods.
• Reputation and Consumer Perception: The association of phthalates with hormone disruption and fertility concerns can lead to significant brand damage and loss of consumer trust.
• Product Recalls: Lack of proactive testing and documentation may result in recalls, financial losses, and liability issues.

Health Concerns

Phthalate exposure, particularly over the long term, has been associated with:

• Endocrine disruption affecting hormone function and development
• Reproductive toxicity and fertility issues
• Developmental disorders in infants and children
• Increased risk of metabolic disorders such as obesity and insulin resistance

Importance of Phthalate Testing in the Food Industry

 Standards and regulations

• India (FSSAI):
  Under the Food Safety and Standards (Packaging) Amendment Regulations, 2021, DEHP is limited to a migration level of ≤ 1.5 mg/kg in food contact plastics.
• USA (FDA & EPA):
• As of May 2022, the FDA revoked approval for 23 phthalates in food packaging, allowing only 9 specific phthalates to remain in use.
• The EPA limits DEHP in drinking water to 6 ppb to reduce chemical exposure.

• European Union (EU):
• Under EU Regulation 10/2011 (amended in 2023), DEHP is allowed only in repeated-use materials contacting non-fatty foods, with a migration limit of 0.6 mg/kg.
• The EU also sets tolerable daily intake (TDI) values to ensure safe consumer exposure.

Testing Methods for Phthalates

• GC-MS (Gas Chromatography-Mass Spectrometry): Gold standard for detecting and quantifying individual phthalates in food and FCMs.
• LC-MS/MS: Suitable for complex matrices and trace-level quantification.
• Migration Simulation Testing: Assesses plasticizer transfer into food simulants under standardized conditions.
• FTIR and ATR-FTIR: Used for surface analysis and detection in plastic films and materials.

Eurofins Testing Services for Phthalates

Eurofins provides a comprehensive suite of analytical and regulatory services for phthalate detection, migration evaluation, and packaging safety validation. Services include:

• Identification and quantification of all regulated phthalates (e.g., DEHP, DBP, DINP, DIDP, BBP) in food products, food contact materials (FCMs), and environmental samples.
• Migration testing from food contact materials following EU Regulation (EU) 10/2011, US FDA, and Codex Alimentarius protocols for specific migration limits (SMLs).
• Customized migration simulation studies using appropriate food simulants (ethanol, acetic acid, vegetable oil, isooctane, etc.) under varied temperature and time conditions to replicate worst-case scenarios.
• Screening of raw materials, masterbatches, printing inks, adhesives, and coatings for phthalates and other plasticizers.
• Surface analysis using FTIR, ATR-FTIR, and SEM-EDX to detect phthalate presence in packaging films, laminates, and composite materials.
• Comprehensive packaging compliance testing, including global declaration of compliance (DoC), NIAS (non-intentionally added substances) analysis, and sensory evaluation.
• Multi-residue screening for other contaminants such as bisphenols (e.g., BPA), primary aromatic amines (PAAs), and MOSH/MOAH.
• Toxicological risk assessment of detected substances in collaboration with regulatory toxicologists.
• Regulatory documentation and dossier preparation for market access in the EU, US, Middle East, and Asia-Pacific.
• Training and consulting support for packaging safety audits, raw material qualification, and supply chain compliance. of all regulated phthalates** in food, packaging, and environmental samples
• Migration testing from food contact materials per EU, FDA, and Codex guidelines
• Custom simulation studies using food simulants (e.g., ethanol, acetic acid, oil) under varying time-temperature conditions
• Screening of raw materials, inks, and adhesives used in packaging manufacturing
• Support for packaging certification and declaration of compliance for global market access
• Risk assessment and regulatory documentation for audits and certification bodies.

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