Closer to Zero and PFAS Risk Considerations
Chemical Risk Is Reshaping Food and Beverage Compliance
The modern food and beverage supply chain is entering a new era of risk management driven less by microbial contamination and increasingly by chemical exposure.
While pathogens such as Salmonella and Listeria remain critical food safety concerns, regulatory agencies, retailers, and consumers are placing unprecedented scrutiny on chemical contaminants, including heavy metals and per- and polyfluoroalkyl substances (PFAS).
For food brands, dietary supplement manufacturers, ingredient suppliers, and contract manufacturing organizations (CMOs), the implications are substantial. Organizations now face stricter regulatory thresholds, expanding state disclosure laws, rising class-action litigation, increased retailer compliance requirements, and heightened reputational risk.
Unlike microbial contamination events, chemical contaminants are often persistent, bioaccumulative, and exceptionally difficult to remove once introduced into a supply chain. As a result, chemical contamination testing is rapidly evolving from a regulatory obligation into a core business protection strategy.
Major retailers and distributors are increasingly requiring documented contaminant testing as part of supplier qualification programs, making advanced analytical verification essential for maintaining market access and consumer trust.
Understanding the FDA’s Closer to Zero Initiative
One of the primary drivers behind the growing focus on chemical contamination testing is the evolving regulatory landscape surrounding heavy metals and elemental impurities.
Historically, naturally occurring heavy metals were tolerated within relatively flexible industry limits. However, the U.S. Food and Drug Administration’s (FDA) Closer to Zero initiative has fundamentally changed industry expectations (U.S. FDA, 2021/2025).
The initiative outlines a phased, science-based strategy designed to reduce dietary exposure to lead, arsenic, cadmium, and mercury. These elements naturally occur in soil and groundwater but are intensified by industrial pollution, agricultural runoff, mining activity, and aging infrastructure. Because they are bioaccumulative and associated with serious neurodevelopmental, reproductive, and cardiovascular health risks, regulators are steadily tightening acceptable exposure levels.
The industry has effectively transitioned from historical parts-per-million (ppm) tolerances to modern single-digit parts-per-billion (ppb) expectations.
For manufacturers, the challenge is compounded by increasing state-level regulation. While the FDA continues refining federal action levels for infant and children’s foods, states are implementing independent disclosure mandates. California Assembly Bill 899, for example, requires baby food manufacturers to publicly disclose heavy-metal testing results through accessible consumer reporting mechanisms, such as QR codes (California Assembly Bill 899, 2023).
At the same time, California Proposition 65 continues to impose aggressive reproductive toxicity and carcinogenicity thresholds, including a Maximum Allowable Dose Level (MADL) of just 0.5 µg/day for lead exposure (California EPA OEHHA, 2024).
In a regulatory environment where independent audits have identified elevated heavy metal levels in mainstream dietary supplements and protein products, relying on outdated ppm-based specifications exposes organizations to enforcement actions, product recalls, retailer rejection, and significant litigation exposure.
Why ICP-MS Is Essential for Modern Heavy Metal Analysis
As acceptable contaminant thresholds decrease into the ppb range, traditional wet chemistry methods and legacy colorimetric testing approaches are no longer sufficient.
To achieve modern compliance expectations, manufacturers increasingly rely on Inductively Coupled Plasma Mass Spectrometry (ICP-MS), widely recognized as the gold standard for elemental analysis.
ICP-MS works by introducing a prepared sample into a high-temperature argon plasma, where the sample is atomized and ionized. The ionized sample is then analyzed by a mass spectrometer capable of identifying and quantifying trace elements at extremely low concentrations.
For quality and regulatory teams managing complex food matrices such as botanical extracts, protein powders, marine-derived ingredients, spices, and fortified formulations, ICP-MS provides the sensitivity and precision necessary to produce legally defensible analytical data.
Modern ICP-MS systems also incorporate collision and reaction cell technologies that help eliminate analytical interferences commonly found in complex food ingredients. This enables highly accurate contaminant quantification at single-digit ppb levels.
Understanding the Expanding PFAS Risk Landscape
While heavy metals represent a naturally occurring environmental hazard, PFAS compounds represent one of the most significant man-made contamination challenges facing the modern food industry.
PFAS, commonly referred to as “forever chemicals,” are synthetic compounds characterized by extremely stable carbon-fluorine bonds that resist environmental degradation. As a result, these substances persist in water, soil, crops, livestock, and food processing systems for extended periods of time.
The regulatory discussion surrounding PFAS initially focused on food contact materials such as grease-resistant paper packaging, fluorinated plastics, and coated containers. However, the risk profile has expanded significantly beyond packaging.
Today, contamination concerns increasingly originate upstream through agricultural irrigation, contaminated groundwater, biosolid fertilizers, industrial runoff, and environmental accumulation in raw materials. Consumer awareness surrounding PFAS contamination has also accelerated rapidly, increasing reputational and legal risk for brands associated with detectable PFAS findings.
EPA Drinking Water Standards Are Reshaping Food Industry Expectations
The urgency surrounding PFAS intensified when the U.S. Environmental Protection Agency (EPA) finalized its National Primary Drinking Water Regulation (NPDWR) for six PFAS compounds (U.S. EPA, 2024).
The EPA established enforceable Maximum Contaminant Levels (MCLs) at extremely low thresholds, including 4.0 parts-per-trillion (ppt) for both PFOA and PFOS. Additional regulated PFAS compounds include HFPO-DA, commonly referred to as the GenX chemical.
Although these standards directly govern public water systems, they are increasingly influencing food manufacturing expectations. Agricultural water, ingredient processing water, and beverage formulations are now being evaluated against ultra-trace contamination benchmarks.
Detecting contaminants at the ppt level requires extraordinarily sensitive instrumentation and validated analytical methods, most commonly LC-MS/MS, GC-MS/MS, and high-resolution mass spectrometry platforms.
For perspective, detecting a compound at 4.0 ppt is analytically comparable to identifying a drop of water in five Olympic-sized swimming pools.
Building a Proactive Chemical Mitigation Strategy
Responding to contamination findings after a product has entered distribution is no longer a sustainable compliance strategy. Food and beverage organizations must implement proactive chemical mitigation frameworks directly within their Quality Management Systems (QMS).
Ingredient risk profiling should evaluate inherent contamination vulnerabilities across sourcing regions and ingredient categories. Root vegetables may bioaccumulate lead and cadmium, marine-derived ingredients can concentrate mercury, and crops grown near industrial zones may face elevated PFAS exposure risk. Environmental and agricultural conditions should also be incorporated into supplier risk assessments.
Supplier qualification programs must also evolve beyond generic Certificates of Analysis (CoAs). Quality teams should require third-party laboratory verification, ISO 17025-accredited testing, validated analytical methods, and contaminant specifications aligned with modern ppb and ppt thresholds. A supplier specification stating “less than 1.0 ppm” may no longer provide meaningful regulatory protection in today’s environment.
Additionally, annual verification testing is often insufficient for managing evolving environmental contamination risks. Testing frequencies should adapt based on seasonal crop variations, regional weather events, sourcing changes, environmental incidents, and evolving regulatory expectations.
Selecting the Right Analytical Chemistry Partner
Mitigating modern chemical hazards requires scientific infrastructure and technical expertise that many organizations cannot efficiently maintain internally. As a result, selecting the right analytical laboratory partner has become a critical operational decision.
Manufacturers should evaluate laboratory partners based on matrix-specific validation capabilities, advanced instrumentation infrastructure, and regulatory expertise.
Testing methodologies must be validated for the specific product categories being analyzed. A laboratory experienced primarily in municipal water testing may not possess the extraction expertise necessary for high-fat dairy products, complex botanical matrices, protein concentrates, or finished nutritional formulations.
Laboratory infrastructure should also include modern ICP-MS systems, LC-MS/MS platforms, GC-MS/MS instrumentation, and high-resolution analytical technologies capable of achieving the low reporting limits required for today’s contaminant regulations.
Equally important is the laboratory’s ability to provide regulatory interpretation and risk assessment support. Analytical data alone is insufficient without the scientific and compliance expertise needed to navigate evolving state, federal, and international requirements.
Chemical Risk Management Is Now a Core Business Function
Chemical contamination testing is no longer simply a regulatory checkbox. It has become a foundational component of modern food safety, supplier verification, and brand protection strategies.
As contaminant thresholds continue tightening across global markets, organizations that proactively invest in advanced analytical testing and supplier transparency will be better positioned to maintain retailer confidence, reduce litigation exposure, strengthen consumer trust, and protect long-term brand equity.
Mérieux NutriSciences actively participates in key industry forums such as
IFT FIRST, supporting ongoing discussions around food safety testing, chemical risk management, and advances in analytical chemistry.
By integrating chemical risk management into product development, sourcing, and quality systems, food and beverage manufacturers can build more resilient supply chains in an increasingly scrutinized marketplace.
To learn more about advanced analytical chemistry capabilities for food, beverage, dietary supplement, and ingredient testing, visit our Chemistry Services page.
References
California Assembly Bill 899. (2023). Baby food safety and toxic heavy metals. California Legislative Information. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB899
California Environmental Protection Agency, Office of Environmental Health Hazard Assessment. (2024). Proposition 65 safe harbor levels for chemicals causing reproductive toxicity. https://oehha.ca.gov/proposition-65
U.S. Environmental Protection Agency. (2024). Final national primary drinking water regulation for per- and polyfluoroalkyl substances (PFAS). https://www.epa.gov/sdwa/proposed-pfas-rescission-rule
U.S. Food and Drug Administration. (2025). Closer to Zero: Reducing childhood exposure to contaminants from foods. https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods
