The Challenges of Controlling Heavy Metals in Baby Food:

Operations, Regulations, & Testing

Food Safety & Quality teams across food industry segments are often tasked with ensuring raw ingredient integrity without impacting production timelines. This balancing act has become even more challenging considering increased product demand, pandemic-related disruptions, and growing complexity of the global supply chain.

On February 4, 2021, a Congressional report examining toxic elements in baby foods and a renewed focus on the achievability of new action levels by the FDA, have recently put a spotlight squarely on heavy metal contamination in baby food.

This report included results of 168 baby foods in the US and cited some significant concerns in heavy metal contamination across all suppliers.

Some key findings include:

95% contained Lead, 73% Arsenic, 75% Cadmium, & 32% contained Mercury

25% contained all 4 heavy metals

20% of all baby foods contained more than 10X the 1ppb generally recognized leads threshold.

Rice based cereal posed the most significant risk including high levels of inorganic arsenic, as well as the other 4 metals

The Challenges:

1. HARPC & Preventative Controls 

With the implementation of FSMA in 2011, and application of the Hazard Analysis and Risk-based Preventative Controls (HARPC) in 2015, there was a focus on supply chain management for both microbial and chemical hazards. In response, initial programs primarily focused on microbial risk factors. The focus is now evolving to increase the priority of chemical hazards that may present. Recently, due to other regulatory pressures across food categories such as Prop65, heavy metals, acrylamide, and pesticides have moved up the list as a priority.


2. Regulatory Environment

Further complicating the issue is a lack of clear regulatory guidelines from the FDA for acceptable levels of heavy metals in baby food. 

Outside of a March 6, 2020 constituent update, supporting 2016 Draft Guidance to Industry on the achievability of a 100ppb threshold of Arsenic in rice-based infant cereals, there is no clear guidance for the baby food industry to metric. The closest guidance for reference in the marketplace is in bottled and drinking water limits driven by both the FDA and EPA. 

In lieu of specific regulatory edicts, on March 5, 2021, the FDA Center for Food Safety and Applied Nutrition sent a notification to the baby food manufacturing industry as a reminder of the preventative control provisions already in place as well as outline as to the short and long term plans to address this issue.

"The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards requiring a control. For example, some manufacturers may conduct verification activities like testing the final product," stated Janet Woodcock, Acting Commissioner of Food And Drugs Administration -FDA and Susan T Mayne, Director at CFSAN. 

In addition, the agency reinforced further efforts in identifying action limits, increased inspections, expansion of industry research and elevated sampling and testing.


3. Testing vs. Raw Ingredient Release

Accuracy is critical when testing for heavy metals, especially when the outcome of these results is pivotal in making difficult and potentially costly ingredient acceptance or rejection decisions. The analytical instrumentation itself is sophisticated, sensitive, and expensive and requires highly trained and qualified scientists, and an ISO17025 accredited laboratory to ensure quality. In addition, having the capacity to ensure rapid release of results, and enabling manufacturing to run efficiently is crucial in managing tight supply chains. 


Baby Food Council Proficiency Program

The Baby Food Council recently commissioned Fapas (an ISO/IEC 17043 accredited proficiency provider) for an invitation only proficiency testing round. The Baby Food Council is a group of infant and toddler food companies, supported by key stakeholders, seeking to reduce heavy metals in the companies’ products to as low as reasonably achievable using best-in-class management practices.

The Council was created in January 2019 in partnership with Cornell University and the Environmental Defense Fund. Other Council members are Beech-Nut Nutrition Company, The Hain Celestial Group (Earth’s Best), Gerber Products Company, Danone (Happy Family Organics), and Heathy Babies Bright Futures. Technical advisors are the Food and Drug Administration, the New York State Department of Agriculture and Markets, and U.S. Department of Agriculture.

The goal of the proficiency test was to determine the performance capabilities of the primary laboratories associated with the Baby Food Council for the determination of very low levels (µg/kg) of toxic heavy metals in baby foods.

The Limit of Quantification (LOQ) is defined at the lowest analyte concentration that can be detected with suitable precision and accuracy. The sensitivity of the method must be low enough to ensure sample response is quantifiable near the lowest acceptance limit. The laboratory must be able to meet the LOQ to at least 6 µg/kg in baby foods being that trace amounts may alter the developing brain.


Certified Laboratories- The Results

After accepting the invitation from The Council, Certified Laboratories underwent an intensive proficiency test for baby food. Certified Laboratories are one of only a few laboratories that have passed proficiency testing with z-scores of less than ±2 for all three metals in spiked samples provided by the Baby Food Council.

What this means for the industry, is that Certified Laboratories is a proven and trusted partner who can you provide the timely, actionable results you need in order to manage and mitigate the heavy metals in the supply chain. 

Contact us today to discuss with our inhouse technical experts at both Certified Laboratories & EAS Consulting to build an actionable and sustainable testing program to gain further control of your critical ingredient supply chain today. 

For further information regarding infant food:

Infant Formula Regulations

Topics: Food & Beverage, Heavy Metals