Proposed FDA Limits for Arsenic in Food Target Contaminants in Infant Rice Cereal

Consumer Packaged Goods

Formulations for Infant Rice Cereal
With concerns rising about the amount of metal contaminants found in infant products, what can companies do to meet FDA limits for arsenic in food?
Image Source: Flickr User Brendan C

Arsenic, while more infamously linked to poisons, has historically been considered an essential element for human nutrition and to have medicinal qualities, such as in the treatment of ulcers and sleeping sickness.1 However, in light of recent studies concerning the safety of arsenic in rice-based products, the FDA has offered draft guidance on the amount of inorganic arsenic found in infant rice cereal.

The new proposed limits for arsenic in food would be 100 ppb, matching guidelines already put in place by the European Commission.2  The change would require CPG companies to determine whether their infant food products necessitated reformulation.

FDA Focuses Arsenic Limits On Rice-Based Infant Cereal

These new limits arise from recent research implicating the adverse health effects of inorganic arsenic: Long-term exposure has been shown to increase the risk of developing cancer.3  But studies now suggest that concentrations past a certain threshold need to be avoided. The metal contaminant is also associated with negative impacts upon fetal growth in pregnant women and neurological development in children. In particular, children exposed to higher levels of arsenic have exhibited decreased performance in developmental learning tests. Developing products that satisfy parental requirements for infant health is in the best interest of CPG companies, so ensuring their products avoid these negative associations is important.

The thought of a single contaminant having such a significant effect upon early childhood can be nerve-wracking for parents who have otherwise done everything they can to protect their infant’s health. This is why the FDA is focusing its new limits on rice, a common component of infant cereals.

Rice is prone to exposure to inorganic arsenic due to its being grown in water and the fact that it absorbs the metal more readily than other types of grain. Despite the effects of inorganic arsenic upon everyone, infants and young children receive more attention because they tend to consume more rice-based food products in relation to their body weight than adults. A recent study further reinforced this concern by demonstrating that infants who ate rice-based products excreted higher concentrations of arsenic in their urine than babies who did not.4  Professionals often advise parents to feed their children infant cereal made from multiple grains instead of simply rice, even though the majority of infant rice cereals available on the market are either at or close to the new proposed maximums.

CPG Food Companies May Adjust Processing and Manufacturing Formulations

To meet the new guidelines, CPG food companies will need to adjust their formulations to comply. In particular, laboratories may need to identify new rice suppliers. Since the amount of absorbed arsenic is dependent upon the individual crop itself, sourcing new rice-based ingredients will be necessary. Another solution may involve finding new methods to grow rice that curtail the amount of arsenic uptake. If that strategy proves difficult to execute, the remaining option will involve developing ways to remove arsenic during the processing and manufacturing process. Regardless of which approach organizations take, collaboration is key because all interested parties will require the information to make adjustments dependent on findings and experimental results.

FDA Limits for Arsenic in Food May Spread to Other Products

While the current focus of the FDA limits for arsenic in food is infant rice cereal, the health concerns surrounding the contaminant imply that further guidance about other rice-based products is forthcoming. With any luck, the inorganic arsenic levels in other rice-based products will be similar to those found in infant rice cereal and not surpass proposed limits by excessive amounts. In those cases, adjusting existing formulations should be quite possible, provided R&D laboratories find a way to curtail inorganic arsenic concentrations—whether by sourcing different rice suppliers or by finding a means to lower the amounts during the development process.

As society, both young and old, becomes more conscious of health and well-being, CPG companies should consider other potential contaminants in their products as well as arsenic, and determine whether those products need also reformulations. Given increased regulatory scrutiny, the proposed FDA limits of arsenic in food may be the beginning of a persistent trend toward health.

BIOVIA offers many comprehensive digital solutions for companies in various industries. Among them is a solution for Formulations in Consumer Packaged Goods Industries. The solution offers processes that support companies in their quest to develop innovative products as well as adjust existing formulations to meet shifting regulatory guidelines. Its tools enable the sourcing of new ingredients and materials for formulation testing and communication between colleagues who need to share information quickly in order to make effective decisions. By transitioning from outdated data management systems, the digital solution makes is possible to refer to past and current experiments and collected knowledge, a crucial necessity during the reformulation process. If your CPG company is interested in an integrated solution to support its R&D process, contact us today.

  1.  “Arsenic Bad, Good or Both?” 1997,
  2.  “FDA targets arsenic in baby cereal,” April 6, 2016,
  3. “Rice Cereal for Babies: What Parents Need to Know about Arsenic in Rice,” July 12, 2016,
  4.  “Infants who ate rice, rice products had higher urinary concentrations of arsenic,” April 25, 2016,