Lists of Select Chemicals in the Food Supply Under FDA Review

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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 or notifications, and on the agency’s initiative when a review is warranted based on scientific evidence. We may reassess the safety of food ingredients, food contact substances, and contaminants as new, relevant data become available.

The following lists include select food ingredients (including food and color additives), food contact substances, and contaminants under FDA review as of July 12, 2023. While these are not intended to be comprehensive lists of the chemicals under the FDA’s review, they represent some of the chemicals that are of high interest among stakeholders who have asked the FDA to review their safety. They also include contaminants that we are focused on as part of our established programs, such as the Closer to Zero initiative. The FDA anticipates updating these lists periodically.

List of Select Food Ingredients and Food Contact Substances Currently Under FDA Review

The following list includes select food ingredients and food contact substances under FDA review as of July 12, 2023. The FDA has previously reviewed the food ingredients or food contact substances listed in the table. These 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. Other reviews on this list are in response to petitions or notifications, 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 a chemical is unsafe, further action may be 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, issuing alerts and informing consumers.

Chemical	Type	More Information about the FDA's Review
Authorized PFAS: Certain Short-Chain Per- and Polyfluoroalkyl Substances (PFAS)	Food Contact Substance	The FDA’s review of the available information about certain short-chain PFAS raised safety questions. The FDA is working with industry to phase-out these PFAS from products on the market, similar to our actions to remove long-chain PFAS. The agency also continues research to better understand the health effects of short-chain PFAS. See the FDA’s PFAS page for more information about our activities.
Authorized PFAS: Uses of other Per- and Polyfluoroalkyl Substances (PFAS) in food contact applications	Food Contact Substance	The FDA monitors the latest information about all remaining authorized uses of PFAS in food contact applications, such as nonstick cookware, and 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. The FDA is also currently reviewing a Citizen Petition. See the FDA’s PFAS page for more information about authorized uses of PFAS.
Bisphenol A (BPA)	Food Contact Substance	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. See the FDA’s BPA page for more information about past FDA reviews and other activities.
Brominated-Vegetable-Oil (BVO)	Food Additive	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. The FDA is evaluating the results from these studies and other available information as the agency works on a proposed rule to amend our regulations to remove the authorization of the use of BVO as a food ingredient. See the FDA’s BVO page for more information about our activities.
Fluorinated High-Density polyethylene (HDPE)	Food Contact Substance	The FDA reviews available data, including comments from the request for information issued on July 20, 2022. See the FDA’s announcement for more information about our activities.
Irgafos 168 (Tris(2,4-di-tert-butylphenyl) phosphite)	Food Contact Substance	The FDA’s review concluded that Irgafos 168 is safe under current conditions of use and the review was presented in 2021. The FDA’s scientific publication is pending.
Partially Hydrogenated Oil (PHO)	Certain uses of PHOs were considered GRAS until 2015, when the FDA revoked this status. Other uses of PHOs are listed in food standards and are prior-sanctioned.	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. See the FDA’s Trans Fat page for more information about our activities.
Phthalates	Certain uses are authorized as Food Contact Substances. Other uses are prior-sanctioned.	In response to a petition from industry, the FDA deauthorized the use of 23 phthalates in food on May 20, 2022. The FDA also issued a request for information on May 20, 2022, to obtain information on the remaining authorized phthalates and is reviewing comments received. The FDA also continues to review a petition and objections to the agency’s previous actions on phthalates. See the FDA’s phthalates page for more information about our activities.
Red Dye No. 3	Color Additive	The FDA evaluates information about red dye no. 3 as it becomes available. The FDA is also currently reviewing a Color Additive Petition filed on February 17, 2023. See the FDA’s color additives page for more information about past FDA reviews and other activities related to food colors.
Titanium Dioxide	Color Additive	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.

List of Select Contaminants Currently Under FDA Review

The following list includes some environmental and process contaminants under FDA review as of July 12, 2023. 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.

Chemical	Type	More Information about the FDA's Review
Arsenic	Environmental Contaminant	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. See the FDA’s arsenic page for more information about our activities.
Cadmium	Environmental Contaminant	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. See the FDA’s environmental contaminants page for more information about our activities.
Lead	Environmental Contaminant	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 guidance to industry on action levels for lead in processed foods that are intended for babies and children under two years of age. See the FDA’s lead page for more information about our activities.
4-MEI Methylimidazole CAS Number 822-36-6	Process contaminant in some caramel colors and flavors, and in some foods and beverages during the normal cooking process	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. See the FDA’s 4-MEI page for more information about our activities.
Mercury	Environmental Contaminant	The FDA s analyzes the results of total methylmercury levels in foods through several testing programs and surveys. The FDA is collaborating 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. See the FDA’s mercury page for more information about our activities.
3-Monochloropropane-1,2-diol (MCPD) esters and Glycidyl Esters (GE)	Process contaminants that can occur in refined edible oils, such as vegetable oils, and foods made with these oils, including infant formula	The FDA analyzes infant formula and other foods made with refined edible oils to evaluate levels of 3-MCPDE and GE and has engaged with industry to learn about mitigation efforts and to encourage reductions in 3-MCPDE and GE levels in U.S. infant formula. See the FDA’s 3-MCPDE/GE page for more information on our activities.
Per- and Polyfluoroalkyl Substances (PFAS)	Environmental Contaminant	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. See the FDA’s PFAS page for more information about our activities.
Thallium	Environmental Contaminant	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. Recently, 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. See the FDA’s Total Diet Study page for more information about our activities related to testing for thallium in bottled water.

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