“Baby food manufacturers hold a special position of public trust. But consumers mistakenly believe that these companies would not sell unsafe products. The Subcommittee’s staff report found that these manufacturers knowingly sell baby food containing high levels of toxic heavy metals. I hope companies will commit to making safer baby foods. Regardless, it’s time that we develop much better standards for the sake of future generations.”
The Baby Food Safety Act was introduced in Senate on 25 March, 2021 and called to amend the Federal Food, Drug, and Cosmetic Act to limit the presence of toxic elements in, and otherwise regulate, infant and toddler food, as well as for other purposes. While the bill is called the Baby Food Safety Act, section 201 ‘Definition of infant and toddler food’ specifically calls for an important amended definition:
Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end, the following:
“(ss) The term ‘infant and toddler food’ means food intended for sale to children up to 36 months of age, including infant formula.
Here, we’ll explore ingredients that are possible sources of heavy metals and other contaminants of concern within infant formula.
Potential high risk for heavy metal ingredients in infant formula
Formula is the exclusive source of nutrition for many infants during their most vulnerable stage of development. According to UNICEF, the first 1,000 days of life – between a woman’s pregnancy and her child’s second birthday – is a unique period of opportunity to establish the foundations for optimum health and development across the lifespan. The right nutrition and care during this window influences not only whether the child will survive, but also his or her ability to grow, learn and rise out of poverty. As such, it contributes to society’s long-term health, stability and prosperity.
Infant formula is designed as a complete substitute for human milk to meet the full nutritional needs of babies under 12 months of age. Internationally, the required components for formulas are set by the Codex Alimentarius, a joint food standards programme overseen by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). Individual countries can also set additional guidelines.
In total, the codex lists more than 30 required nutritional ingredients for infant formula, including vitamins and minerals, fats, proteins and carbohydrates – the primary building blocks that little humans need to grow and develop. Not only is including these sources important and required, but the quality of these ingredients is key. Here are a few ingredients to pay attention to when it comes to heavy metal risk.
Vitamins and minerals
Heavy metals are naturally occurring in the earth’s crust, but due to human causes like mining, fracking and industrial agriculture, these metals can become more heavily concentrated in some soils given their proximity to the industrial activity.
When it comes to minerals, sometimes these ingredients are mined, increasing their likelihood of contamination with other mined minerals like heavy metals.
While the focus of late has been on heavy metals, it doesn’t mean that formula manufacturers shouldn’t examine additional sources of potential contamination within their supply chain
With vitamins, oftentimes these ingredients are imported. While we may have some of the most progressive food safety and environmental regulatory policies, we can’t always say the same for the vitamin or mineral ingredient’s country of origin.
Make sure you request a Certificate of Analysis down to single digit parts per billion for these ingredients. Better yet, routinely perform independent testing to confirm that your supplier is staying true to their word.
Whether brown rice syrup as a carbohydrate or a rice powder as a thickener, a variety of rice-based ingredients may be used in infant formula. However, rice has been identified as a high-risk source of arsenic contamination.
Use testing to confirm the arsenic levels in any rice-based ingredient you may be using.
The water source
Any type of food production requires full knowledge of the quality and safety of the water used for cleaning and production. With traditional food safety audits, many of us are guilty of simply sending out water samples for microbial testing.
When was the last time you submitted your water samples for heavy metals testing? When was the last time you asked your ingredient suppliers for a copy of their water testing report, including heavy metals? In light of the ageing infrastructure under major cities, consider sending out water samples annually for a heavy metal analysis. Make sure that the sensitivity is down to single digit ppb.
Other contaminants within infant formula
While the focus of late has been on heavy metals, it doesn’t mean that formula manufacturers shouldn’t examine additional sources of potential contamination within their supply chain. Here are a few to consider.
The FDA has long banned bisphenol A (BPA)-based epoxy resins as coatings in infant formula packaging. It was largely abandoned by manufacturers anyway, given that it fell out of favour with consumers following reports that BPA was linked to endocrine disruption and infertility. However, reports from Clean Label Project and Environmental Working Group have found BPA contamination in some baby food products. The source; potentially the use of BPA-lined containers or packaging further up the supply chain. While the use of the words ‘BPA-free’ has become commonplace, finished product manufacturers may only be considering their finished product packaging and not the potential for BPA contamination during the manufacturing process.
It’s never too late to work with your suppliers to better understand their manufacturing surfaces and in-process product packaging, to minimise your finished product contamination risk from BPA.
Melamine and its analogues
While over a decade since its occurrence, it’s hard to forget about the 2008 Chinese milk scandal, which involved milk and infant formula along with other food materials and components being adulterated with melamine. Melamine can be used to artificially spike the results for protein when a product is tested. It is also linked to kidney damage. The melamine food scare of 2008 resulted in the death of six babies and over 54,000 being hospitalised. In this case, it wasn’t a contamination issue, but rather an intentional adulteration of the product to pass necessary quality assurance measurements through the use of a cheap (and deadly) filler.
If you have concerns about the protein content of your product; if certain test results and prices look too good to be true; or even if you are sourcing from a new supplier, consider melamine and its analogues (cyanuric acid, ammeline and ammelide) testing, just to make sure that the product is safe.
According to the International Baby Food Action Network (IBFAN), powdered formulas are not sterile products and may become contaminated during the manufacturing process by harmful bacteria such as species of Salmonella and Cronobacter/Enterobacter.
According to the Centers for Disease Control (CDC), getting sick from Cronobacter does not happen often, but infections in infants can be deadly.
Cronobacter sakazakii, formerly known as Enterobacter sakazakii, is a germ found naturally in the environment. The germs can live in dry foods, such as powdered infant formula, powdered milk, herbal teas and starches. Cronobacter can cause diarrhoea and urinary tract infections in people of all ages, but infection can be very serious in infants. As a member of the Enterobacteriaceae, it is susceptible to heat and therefore unlikely to survive the production processes involved in the manufacture of formula. However, it is widespread in the environment and can contaminate post process either from heat-sensitive additives such as micronutrients or from the general factory environment.
Through routine testing you can help make sure that your product stays safe.
While the Baby Food Safety Act of 2021 has not yet been signed into law, be proactive in helping to maintain and restore consumer trust in products intended for these vulnerable populations.
About the author
Jaclyn Bowen MPH, MS is the Executive Director of Clean Label Project and a food safety and quality systems engineer. Prior to coming to the Clean Label Project, she spent 15 years at the World Health Organization Collaborating Centre, NSF International, working on the creation and enforcement of food safety and water quality standards and compliance systems.