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  1. Food Chemical Safety

List of Select Chemicals in the Food Supply Under FDA Review

Back to Food Chemical Safety

The FDA assesses the safety of exposure to chemicals in the food supply. This includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants.

The FDA may initiate post-market assessments in response to requests from external stakeholders, such as through petitions, and on the agency’s initiative when a review is warranted based on new information. We may reassess the safety of food ingredients, food contact substances, and contaminants as new, relevant data become available. The FDA is committed to continuing its evaluation of all relevant scientific information and data when considering whether regulatory action is warranted to ensure the safety of the food supply.

The table below includes select food ingredients (including food and color additives), food contact substances, and contaminants under FDA review as of September 24, 2024. While this table is not intended to be a comprehensive list, it includes some of the contaminants that we are focused on as part of our established programs, such as the Closer to Zero initiative. It also includes some of the chemicals that are of interest among stakeholders who have asked the FDA to review their safety through petitions, including citizen petitions. The FDA anticipates updating this table regularly to provide transparency on our reviews of chemicals in the food supply.

Information about the Food Ingredients and Food Contact Substances Listed in the Table

The FDA has previously reviewed the food ingredients or food contact substances listed in the table. Our reassessments will help fill data gaps and follow up on information reported in the literature and other available information, focusing on food ingredients and food contact substances that may present the most significant public health concerns. Our reassessments are also in response to petitions, which is a way for stakeholders to ask the FDA to establish or change a regulation or to take other administrative action. If new information becomes available from our reassessments indicating that the intended use in food of a chemical is unsafe, the FDA would take further action as warranted. Depending on the results of our reassessments, some of these actions may include revoking authorizations or approvals for certain uses, working with industry on voluntary market phase-out agreements and recalls, and issuing alerts and informing consumers.

Information about the Contaminants Listed in the Table

The table includes some environmental and process contaminants under FDA review. The FDA monitors the food supply for contaminants by testing both domestic and imported foods through several different programs. We are currently reviewing the items on the list below to inform our regulatory actions and help minimize, to the greatest extent possible, consumers’ exposure to unavoidable contaminants from foods. Action levels are one regulatory tool the FDA uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable. While action levels do not establish a permissible level of contamination, they indicate a level of contamination at which a food may be regarded as adulterated under the law.

Search the table below by chemical name, type, or other details shown in the table to find more information about our reviews.

Chemical Name Type Status More Information about the FDA's Review

Authorized PFAS: Certain Short-Chain Per- and Polyfluoroalkyl Substances (PFAS) in food contact and paperboard
Other names include: 6:2 fluorotelomer alcohol (6:2 FTOH)

Food Contact Substance Risk Management Action

Following an FDA safety review, Industry agreed to phase out substances containing PFAS authorized for use on food contact paper and paperboard. In February 2024, the FDA announced that all grease-proofing agents containing PFAS are no longer being sold in the U.S. For more information, please see Authorized Uses of PFAS in Food Contact Applications and Market Phase-Out of Grease-Proofing Substances Containing PFAS. The agency also continues research to better understand the health effects of short-chain PFAS.

Read more about PFAS.

Authorized PFAS: Uses of other Per- and Polyfluoroalkyl Substances (PFAS) in food contact applications Food Contact Substance Risk and Safety Assessment

The FDA monitors the latest information about all remaining authorized uses of PFAS in food contact applications, such as processing equipment. These uses are primarily for durable repeat use equipment where the equipment manufacturing process results in negligible potential for migration and human exposure through food. This would include PFAS that are not short- or long-chain, which are addressed by other FDA initiatives.

Read more about PFAS.

Arsenic Environmental Contaminant Risk Management Review

The FDA analyzes total and inorganic arsenic levels in foods collected through several testing programs and surveys. The FDA is also working to identify an interim reference level for inorganic arsenic, including consulting with Environmental Protection Agency on their work to develop toxicological reference values for use in human health assessments. The FDA is also working on developing action levels for inorganic arsenic in foods consumed by infants and young children. On June 1, 2023, the FDA issued guidance to industry on an action level for inorganic arsenic in ready to drink apple juice.

Read more about arsenic.

Bisphenol A (BPA) Food Contact Substance Risk and Safety Assessment

The FDA evaluates information about BPA as it becomes available. The FDA is also currently reviewing a Food Additive Petition filed on May 2, 2022.

Read more about BPA.

Brominated Vegetable Oil (BVO) Food Ingredient Risk Management Action

The FDA evaluated the available information about BVO and identified areas where additional information about possible health effects was needed. The FDA also collaborated on studies with the National Institute of Environmental Health Sciences. On July 3, 2024, the FDA issued a final rule to revoke the regulation allowing the use of BVO in food.

Read more about BVO.

Cadmium Environmental Contaminant Risk Management Action

The FDA analyzes the results of cadmium levels in foods through several testing programs and surveys. The FDA also plans to update estimates of exposure to cadmium using updated survey data from the Total Diet Study. The FDA is also working on developing draft action levels for cadmium in foods intended for infants and young children.

Read more about cadmium.

FD&C Red No. 3 Food Ingredient Risk Management Review

The FDA evaluates information about FD&C Red No. 3 as it becomes available.

The FDA is also currently reviewing a Color Additive Petition filed on November 15, 2022.

Read more about FD&C Red No. 3

Fluorinated High-Density polyethylene (HDPE) Food Contact Substance Review of Information

The FDA reviews available data, including comments from the request for information issued on July 20, 2022.

Read more Fluorinated Polyethylene Food Contact Containers.

Irgafos 168 (Tris(2,4-di-tert-butylphenyl) phosphite) Food Contact Substance Risk Management Action

The FDA’s review concluded that Irgafos 168 is safe under current conditions of use and the review was presented in 2021 and no risk management action is warranted. On June 17, 2023, the FDA published the review.

Read more about Irgafos.

Lead Environmental Contaminant Risk Management Action

The FDA analyzes the results of lead levels in foods through several testing programs and surveys. The FDA plans to update estimates of exposure to lead using updated survey data from the Total Diet Study. On January 24, 2023, the FDA issued draft guidance to industry on action levels for lead in processed foods that are intended for babies and children under two years of age. The FDA is also working on finalizing action levels for lead in juice and lead in foods intended for babies and young children. In 2024, the FDA has taken steps to monitor lead in ground cinnamon following the investigation of elevated lead and chromium levels in apple cinnamon puree products.

Read more about lead.

4-MEI
4-Methylimidazole
CAS Number 822-36-6

Food Ingredient Impurity and Process Contaminant Risk Management Review

The FDA has evaluated data on potential safety concerns with higher levels of 4-MEI. The FDA is working to obtain information on current levels and manufacturing controls to ensure caramel used in foods does not contain 4-MEI at levels that would raise concerns.

Read more about 4-MEI.

Mercury Environmental Contaminant Risk Management Review

The FDA analyzes the results of total mercury and methylmercury levels in foods through several testing programs and surveys. The FDA has collaborated with other federal agencies to support the National Academies of Sciences, Engineering, and Medicine’s review of the available data related to the scientific evidence regarding seafood and child growth and development to support a more holistic view of seafood consumption. In May 2024, NASEM published the final version of the FDA co-sponsored report. The agency is considering the findings in the NASEM report, along with other data and information, to inform the joint FDA and EPA Advice About Eating Fish and the Closer to Zero Initiative.

Read more about mercury.

3-Monochloropropane-1,2-diol (MCPD) esters and Glycidyl Esters (GE) Process Contaminant Risk Management Action

The FDA analyzes infant formula and other foods made with refined edible oils, such as vegetable oils, to evaluate levels of 3-MCPDE and GE. The FDA engaged with industry to discuss mitigation efforts and encourage reductions in 3-MCPDE and GE levels in U.S. infant formula. The FDA’s recent testing results show reduced 3-MCPDE and GE in infant formula products. The FDA will continue to monitor the levels of 3-MCPDE and GE in infant formulas.

Read more about 3-MCPDE/GE.

Mycotoxins (T-2 toxin, HT-2 toxin and zearalenone) Environmental Contaminant Risk Management Review

The FDA has recently updated the mycotoxin compliance program for human food to include monitoring of additional mycotoxins of regulatory interest. The new data will support enforcement actions, risk assessments, and international activities, as well as provide information on mycotoxin incidence, extent of contamination, and co-occurrence.

On May 31, 2024, the FDA announced that sufficient laboratory capacity has been reached for certain import-related food testing, specifically for mycotoxins, under the Laboratory Accreditation for Analyses of Foods program.

Read more about mycotoxins.

Partially Hydrogenated Oil (PHO) Food Ingredient Risk Management Action

The FDA reviewed the available scientific evidence about the health risks associated with the consumption of PHOs, including the findings of expert scientific panels. We also reviewed food additive petitions from industry and NGOs. In 2015, the FDA revoked the GRAS status for PHOs. For most uses of PHOs, the FDA also established June 18, 2018, as the date after which manufacturers could no longer add PHOs to food. We are currently updating our regulations to remove all mention of PHOs from the FDA's regulations and as an ingredient in standards of identity. We are also revoking all prior sanctions for uses of PHOs in food. On December 13, 2023, the FDA announced the effective date for the direct final rule regarding the revocation of uses of PHOs in food.

Read more about PHOs (see Trans Fat).

Per- and Polyfluoroalkyl Substances (PFAS) Environmental Contaminant Review of Information

The FDA analyzes foods and reviews the available data, including evaluating exposure from seafood using the agency’s Total Diet Study samples and other surveys. On March 20, 2024, the FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. It gave the FDA the ability to help prevent entry of human food products into the U.S. if they are found to be contaminated with PFAS, among other contaminants. On April 18, 2024, the FDA shared updates on agency activities to better understand PFAS in the general food supply, including recent testing results, continued efforts to supplement PFAS data and monitoring activities, and an updated analytical method to measure PFAS. 

Read more about PFAS.

Phthalates
Other names include: ortho-phthalates, plasticizers, and components of adhesives, resins, lubricants, and sealants

Food Contact Substance Risk and Safety Assessment

The FDA is working on an updated safety assessment of the remaining authorized uses of phthalates, including considering information the FDA has received through a request for information.  

On May 20, 2022, the FDA deauthorized the use of 23 phthalates in food in response to a petition from industry, and issued a request for information for safety and use information on the nine remaining authorized phthalates. On July 21, 2023, the FDA responded to a petition related to the agency’s actions. On October 29, 2024, the FDA responded to objections on the agency’s final rule. The FDA evaluated the objections and concluded that they did not provide a basis for modifying the final rule. 

Read more about phthalates.

Potassium Bromate Food Ingredient Review of Information

The FDA worked with the American Bakers Association to help industry improve baking technology and testing so that the ingredient is used in a way that minimizes residual bromate levels to ensure safety.

Read more about potassium bromate.

Propylparaben Food Ingredient and Food Contact Substance Risk and Safety Assessment

The FDA evaluates information about propylparaben as it becomes available.

Read more about propylparaben.

Thallium Environmental Contaminant Risk and Safety Assessment

The FDA analyzes the results of thallium levels in foods, and we are reviewing published studies on thallium toxicity. The FDA also plans to review results from ongoing U.S. National Toxicology Program studies when they become available. In 2023, the U.S. delegation to the Codex Committee on Contaminants in Foods nominated thallium to the Priority List of Contaminants and Naturally Occurring Toxicants for Evaluation by the FAO/WHO Joint Expert Committee on Food Additives (JECFA). This nomination will encourage countries worldwide to collect occurrence data and toxicology information for a future risk evaluation by JECFA.

Read more about our activities related to testing for thallium in bottled water through the Total Diet Study.

Titanium Dioxide Food Ingredient Risk and Safety Assessment

The FDA evaluates new information about titanium dioxide as it becomes available, including reviewing safety assessments and actions by other regulatory authorities.

The FDA is also currently reviewing a Color Additive Petition filed on April 14, 2023.

Read more about titanium dioxide.

Table Definitions:

  • Environmental Contaminant: A chemical not intentionally added to foods but present in foods because they are in the soil, water, or air where foods are grown, raised, or processed and that have the potential to cause harm.
  • Food Contact Substance: A chemical that comes into contact with food and is not intended to have a technical effect in such food. This includes substances used in food packaging and its components, processing equipment, food preparation surfaces, or cookware.
  • Food Contact Substance Impurity: A chemical component of the food contact substance that is not the food contact substance itself.
  • Food Ingredient Impurity: A chemical component of an ingredient that is not the ingredient itself.
  • Process Contaminant: Undesired chemical by-products that can form during food processing, especially when heating, drying, or fermenting foods.

Steps in Our Risk Reviews

For each of the chemicals in this table, we are progressing through a series of steps to evaluate its potential risks. The process is a science-based, iterative approach to continually evaluate risks over time. Evaluating the risks of chemicals in the food supply is part of our commitment to food safety.

Risk Reviews of Chemicals in the Food Supply: Step 1 Review Information

Review of Information

The FDA reviews information about a food ingredient, food contact substance or contaminant to determine if we need to move into Risk and Safety Assessment. We may obtain this information by participating in international scientific and standard-setting activities, attending scientific conferences, and other means of engaging with public health and research stakeholders. We also review peer reviewed scientific literature and information released by other agencies.

Risk Reviews of Chemicals in the Food Supply: Step 2 Risk and Safety Assessment

Risk and Safety Assessment

The FDA assesses whether available information about a chemical suggests a possible safety concern. We assess the possible health effects on consumers, including vulnerable populations like children, by understanding the risk, the level (or amount) of the chemical that would produce the risk, and compare it to the level of the chemical in food. To do this, we use tools and data in toxicology, exposure assessment and mathematical modeling, prioritization, and assessment, some of which the FDA has developed. Once completed, the agency moves into Risk Management Review.

Risk Reviews of Chemicals in the Food Supply: Step 3 Risk Management Review

Risk Management Review

The FDA moves from assessment to determining whether action is necessary to protect public health. The FDA may request new data from industry or other stakeholders, collect new analytical or exposure information or conduct exposure or safety studies. Results from these data and studies help determine whether the agency takes a Risk Management Action.

Risk Reviews of Chemicals in the Food Supply: Step 4 Risk Management Action

Risk Management Action

Actions the FDA takes to protect public health may include revoking authorizations or approvals for certain uses, working with industry on voluntary market phase-out agreements and recalls, developing action levels for contaminants, issuing alerts, and informing consumers and industry. The FDA continues monitoring new information for possible safety issues and takes additional actions if warranted, including Review of Information, Risk and Safety Assessment or Risk Management Review.

Infographic of the Steps in Our Risk Reviews (PDF: 848KB)


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