Flavors for Baby Food

Luke Grocholl, Regulatory Affairs Expert

Sigma-Aldrich® Flavors & Fragrances

Glasses of baby puree

Introducing Solid Food is an Important Developmental Milestone

As any parent will attest, each baby is ready for the next developmental stage at a different age. Introducing solid food (often in the form of a puree) into a baby’s diet is one example: experts agree that most are ready at six months old, with some babies eating solids as early as four months, and others needing until they are eight months old. This important milestone in a baby’s development allows parents to introduce a variety of foods to children, though it is generally bland to begin, as adults can consume spices or strong flavors that babies cannot tolerate. Despite this, babies do gradually enjoy new tastes, and therefore the flavor industry can play an important role. However, special precautions and guidance exist for baby food flavors to ensure they are both safe and appropriate for consumption.

Risks of Toxic Metals in Baby Food

Taste is not the only concern for very young children; their rapidly-growing bodies can be more susceptible to environmental hazards. For this reason, the FDA developed the Closer to Zero program1 to study the level of heavy metals in commercially-available baby food, assess the potential risks from the toxic metals, and set standards and guidance regarding safe levels for baby food. Closer to Zero focuses on four elements with known toxicity for children and infants: arsenic, cadmium, mercury, and lead. In a report published on February 4, 2021 by the US House of Representatives,2 an investigation of commercially-available baby foods found high levels of toxic metals by the industry’s own data including arsenic levels as high as 180 ppb,3 and over 900 ppb in individual ingredients. Similarly, the report found lead concentrations over 640 ppb in some baby food with individual ingredients having over 800 ppb. For cadmium, levels in ingredients exceeded 340 ppb, and there was with limited availability of data on the total amount in the finished product. The report also found that most producers in the industry do not test for mercury and for those that did test, mercury levels of up to 10 ppb in finished food was detected. The report also identified that some of these levels were above the participating companies’ internal policies, but because there was no clear regulatory limit of these toxic metals in baby food, the products could still be released into the market.

The report concluded that more oversight and guidance is needed. Congress therefore directed the FDA to review the report and gather additional input in order to set standards for toxic metals in baby food. It is important to note that the report stated that though guidelines do exist for tolerance of heavy metals in drinking and bottled water that are much lower than some of the levels detected in baby food, they should be used for comparative purposes only.

Purification methods can be very efficient at removing toxic metals from water, but are often less effective in a complex matrix like food. Similarly, analytical methods including sample preparation can have very low detection thresholds for metals in water but much higher thresholds in food matrices. Sample preparation is usually a particularly challenging part of these analytical methods. As a result of the complex matrix of food, comparisons to water tolerances in the Closer to Zero report cannot be applied directly. Table 1 summarizes the findings of the report and the current federal limits of toxic metals in bottled water.

Table 1.Maximum levels of toxic metals found in commercial baby food

It should be noted that although there is no general standard for baby foods, some specific foods do have toxic metal limits. For example, the federal standard for arsenic in infant rice cereal is ≤ 100 ppb and ≤ 10 ppb in apple juice.

The Closer to Zero program sets several goals for the FDA in regulating toxic metals in baby foods including mandatory toxic metal testing for both ingredients and finished products and setting standards for toxic metals. The program also encourages baby food produces to phase out higher-risk ingredients. This phase-out could create opportunity for the flavor industry where, in reducing and removing higher-risk ingredients, the industry may turn to flavorists to maintain or improve palatability safely.

Pesticides in Baby Food Regulation in the EU

As the US is looking to reduce and control toxic metals, other regions are focusing on other potential risks. The EU, for example, requires that there be no detectable pesticides in baby food.4 As noted above, analysis of potential contaminants in a complex matrix such as baby food can be difficult. To address this, the EU defines that “not detectable” means below a detection limit of 10 ppb. In addition to limiting baby food to ≤ 10 ppb pesticide in most cases, the EU also identified some pesticides with higher toxicity to infants and set detection limits below that threshold. This approach to pesticides has proven popular and other regions have sought similar limits. Groups in New Zealand, for example, petitioned their government to adopt similar requirements for pesticides as the EU.5

Consumer Demand for Natural Flavors in Baby Food and its Impacts on Food Safety

Because artificial flavors are not derived from botanicals, they may be inherently free from the risk of pesticides, and are often at lower risk from toxic metals that are often derived from environmental sources such as ground water. Consumer demand, however, heavily favors natural ingredients especially in the context of baby food, as parents are often more conscious of artificial ingredients in the food they feed their infants than in the food they consume themselves. The public perception that natural flavors are a healthier alternative to artificial flavors will likely drive baby food producers to choose natural flavors over synthetic alternatives.

Flavorings are Subject to Regulations of Food Contaminants

As a result of the special vulnerability of infants and very young children to toxicity from food contaminants, regulatory agencies are gathering data and establishing standards and regulations to help ensure their health and safety. These requirements on tolerable levels of impurities extend beyond the food itself to all of the ingredients used in production, including flavors. Flavor producers should therefore carefully review their ingredients for toxic metal and pesticide levels to ensure all regulatory requirements and safety recommendations are met for the youngest food consumers.


2021. Closer to Zero: Action Plan for Baby Foods. [Internet]. U.S. Food & Drug Administration.[updated 08 Oct 2021]. Available from: https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods
2021. 117th Congress. [Internet]. House Committee on Oversight and Reform.[cited 26 Oct 2021]. Available from: https://oversight.house.gov/news/reports
ppb: Parts per billion also expressed as micrograms per kilogram (µg/kg).
Commission Directive 1990/50/EC.
2015. New Zealand Group Seeks Zero Tolerance for Pesticide Residues in Baby Food. [Internet]. Food Safety News.[updated 30 May 2015]. Available from: https://www.foodsafetynews.com/2015/05/new-zealand-group-seeks-zero-tolerance-for-pesticide-residues-in-baby-food/#.VkRJwq6rTOR