The FDA protects consumers from harmful exposure to chemicals in food that would have an adverse impact on human health, through a comprehensive, science-driven, and modernized approach.
The FDA helps to safeguard the food supply by evaluating the use of chemicals as food ingredients and substances that come into contact with food, such as through food packaging, storage or other handling to ensure these uses are safe. The FDA also monitors the food supply for chemical contaminants and takes action when we find that the level of a contaminant causes a food to be unsafe.
Some chemicals are used because they serve a useful purpose in food or food packaging. Chemicals may be used in food, during food production and in packaging to preserve quality, add nutritional value, improve texture and appearance, extend shelf life and protect food from pathogens that can contaminate food and make people sick. These uses of chemicals in food or for food contact must be safe.
Other chemicals may enter the food supply through contamination. For example, environmental contaminants can be present in foods because they are in the soil, water or air where foods are grown, raised or processed. Process contaminants, such as undesired chemical by-products, can form during food processing, especially when heating (cooking), drying or fermenting foods.
Food manufacturers are responsible for marketing safe foods. The food industry has a responsibility to ensure the safety and regulatory status of the chemical substances they use in food or come into contact with food. They are required to implement preventive controls as needed to significantly minimize or prevent exposure to chemicals in foods that are hazardous to human health. The FDA assists the food industry through our regulations, guidance documents and regulatory programs. Our work to date has resulted in significant progress in reducing childhood exposure to contaminants from food and the FDA’s Closer to Zero initiative builds on this progress. The agency also helps support innovation to meet demands for foods made using new technologies, ingredients and food packaging solutions without compromising our safety standards. We provide factual information about chemicals to help people make the best informed decisions about their food choices. These activities occur both before and after products enter the market. The FDA is enhancing our approach to complement our existing activities, subject to additional resources. This will help ensure that our oversight in this area keeps pace with innovation in support of our food safety mission.
The FDA’s Pre-Market Activities: Food additives and color additives must be authorized for their use in food before they enter the market. To obtain this authorization, a manufacturer is required to submit information to the FDA that demonstrates their use meets the safety standard. This submission includes an environmental assessment, unless exempt, for the FDA to review to ensure the use of the additive does not have a significant impact on the environment. The FDA has established several programs to help manufacturers demonstrate with reasonable certainty that a chemical is not harmful when used as proposed. These include:
- Food additives and color additives: Food additives and color additives require pre-market review and approval by the FDA. Manufacturers are required to supply the FDA with evidence that establishes each chemical is safe at its intended level of use before it may be added to foods. In the case of food additives and color additives, manufacturers submit data and information to the FDA as a petition requesting approval of the ingredient for a specific intended use. The FDA evaluates the petition, and other existing data and information to determine if the data available demonstrate that the chemical is safe under the proposed conditions of use. If the FDA determines that the intended use of the additive is safe, the FDA publishes a regulation authorizing its use as a food additive or color additive. That authorization can be relied on by any manufacturer for that intended use.
- Food Contact Substances: Food contact substances are substances that come into contact with food, such as through food packaging, processing, storage or other handling. Companies who wish to use a food contact substance that is a food additive are required to ensure that the food contact substance is authorized by the FDA before marketing the product in the U.S. Information about a food contact substance is typically submitted to the FDA through a food contact notification. The FDA reviews information submitted in the food contact notification, and considers other relevant information available to the FDA, to ensure that the intended use is safe. This process includes analyzing testing data that demonstrates the amount of migration of a food contact substance to food because of its intended use, and toxicological data to ensure that the consumer exposure resulting from this migration is safe. If the FDA determines that the intended use of the substance is safe, the use is authorized under an effective food contact notification. Food contact notifications are specific to the company submitting the notification and to the specified intended use of the substance.
- Generally Recognized as Safe: The definition of food additive in the Federal Food, Drug, and Cosmetic Act excludes the uses of substances that are Generally Recognized as Safe (GRAS) and therefore they do not require pre-market review by the FDA. For the use of a substance to be considered GRAS, all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts. In addition, GRAS uses must meet the same safety standard as for food additives, a reasonable certainty of no harm under the conditions of its intended use and have the same quantity and quality of information that would support the safety of a food additive. The FDA has established a voluntary GRAS notification program to help ensure that these substances are safe under their intended use and to help industry meet its responsibility for ensuring the GRAS status of substances they intend to use in food.
The FDA’s Post-Market Activities: The FDA is engaged in various post-market activities on an ongoing basis to monitor the food supply for chemical contaminants and help ensure chemicals used as food ingredients and substances that come into contact with food are safe. These include:
- Continued Evaluation of Safety Information for Authorized Substances: The FDA reviews new scientific information on the authorized uses of ingredients and food contact substances to ensure that these uses continue to be safe. The FDA reviews petitions or notifications submitted by industry and other stakeholders that necessitate the reassessment of a previously-authorized use. Additionally, FDA scientists proactively reassess a chemical when new information about its safety profile warrants reassessment. These FDA-initiated reassessments are typically conducted on a case-by-case basis and focus on substances that present the greatest public health concerns.
- Monitoring the Food Supply for Contaminants: The FDA monitors the food supply by testing both domestic and imported foods through several different programs. For example, the FDA’s Total Diet Study analyzes the food supply for both nutrients and contaminants, and is an essential tool that helps the FDA prioritize food safety and nutrition efforts.
- Research and Method Development: The FDA conducts a variety of research to address chemical contaminants. For example, the FDA researches how process contaminants form and develops measurement methods that allow us to survey levels of process contaminants in foods and identify actions to reduce or eliminate any potential harmful exposure. The FDA is also focused on improving testing and methods to better estimate exposure to contaminants and identifying ways to prevent or minimize exposure as much as possible.
- International Scientific Activities: The FDA through collaboration with international regulatory partnerships also limits the allowable amount of a chemical contaminant in specific foods when they are otherwise unavoidable. Through our partnerships with international organizations such as the Codex Alimentarius Commission and the Joint FAO/WHO Expert Committee on Food Additives, we develop science-based international food safety standards and guidelines.
- Oversight Activities to Address a Safety Concern: When we identify new data and information that indicates a chemical is unsafe, we take steps to protect public health, which can include revoking authorizations or approvals for certain uses, working with industry on voluntary market phase-out agreements and recalls, issuing alerts and informing consumers.
The FDA evaluates the safety of chemicals in food (both intentionally added and contaminants) and that come into contact with food using the scientific and regulatory tools we have in place while continually evolving to incorporate new approaches. To do this, FDA scientists:
- Stay abreast of advances in food composition including added chemical substances, chemical contaminants, food consumption and the development of new chemicals for use in or with food and methods to evaluate chemical safety.
- Apply our existing authority flexibly and effectively to support rapidly evolving areas of technological innovation, while maintaining our rigorous safety standard.
- Invest resources into building our capacity to collect, analyze and integrate scientific data to assess the safety of chemicals to meet our regulatory responsibilities.
We also identify chemicals for which the science suggests there may be benefit from further research. We conduct toxicological studies when necessary to evaluate a specific issue, collaborate with scientific and public health stakeholders to further support studies and research and request data, whether published or not, from the food industry.
Evaluating the Safety of Chemicals Intentionally Added to Food
When the FDA evaluates if a substance can be safely used in food or come into contact with food we consider all the relevant information, including:
- Information on the identity of the substance, including its chemical structure and what is known about similar substances.
- The amount of the substance that we expect people may be exposed to based on how it will be used and its use level in food.
- Toxicology, safety data and other information to show that the substance is safe at the calculated exposure levels.
We rely on toxicological data to determine if chemicals may be harmful, what the potential health risks are and at what levels of exposure harm might occur. Industry is responsible for ensuring that sufficient data and information are available to ensure the safety of any substance used in food before it can be introduced into the marketplace. This information is critical for the FDA and industry to determine which uses of the chemicals are safe and in what amount. When we identify new data and information that indicates that the use of an authorized substance is no longer safe, we take action, which may include revoking authorizations for certain uses and informing consumers. More information can be found on Overview of Food Ingredients, Additives & Colors.
Evaluating the Safety of Contaminants
The FDA and our state partners regularly monitor the food supply for hundreds of chemical contaminants to help detect when levels in foods may pose a health risk. If a contaminant is detected, to estimate exposure and the potential health risk, we consider the level of the contaminant in the food, consumption estimates, vulnerable sub-populations who may be affected and the most current available toxicological information for that contaminant. If the agency finds that the level of a chemical contaminant in a food poses a potential health risk, we work with the manufacturer to resolve the issue and take action to prevent the product from entering, or remaining in, the U.S. market as well as informing consumers of the health risks. More information can be found on Chemical Contaminants & Pesticides.
To keep pace with an evolving marketplace, the FDA must be equipped to meet both present and future challenges. These include reviewing an increasing number of submissions from industry and other stakeholders to assess the safety of chemicals added to food or that come into contact with food, which have increased in complexity.
We are identifying internal processes that we can build on and strengthen to prioritize our work on activities that have the greatest public health impact for contaminants and the use of chemicals as food ingredients and substances that come into contact with food. For example, adopting new methods and tools will enhance our ability to make science-based decisions and initiate risk reviews when supported by current science. It is critical that we have access to all available data about chemicals, and the resources and tools to assess and integrate these data to sustain this high-priority program area.
Leveraging modern computational, analytical, toxicology and research methods and tools will further improve our oversight of chemicals in food. We are evaluating how to better incorporate modern methods and tools into our safety assessments to help us:
- Better identify and prioritize the potential risks of chemicals to ensure the U.S. food supply remains safe, nutritious and wholesome.
- Strengthen and update existing approaches and processes for evaluating and monitoring chemicals in the U.S. food supply.
Modern methods and tools that leverage new and evolving data sources better support pre-market safety evaluations, including reviews of innovative ingredients and food packaging solutions. Modern methods and tools can also help the FDA prioritize our post-market safety review efforts in a science-based, more systematic way that will focus on the chemicals that present the greatest public health concerns.
This approach will also allow the FDA to monitor the food supply for emerging health concerns from chemical exposures. This would enhance how we integrate and assess new science on the safety of chemicals in food and better inform our actions to reduce harmful exposure to chemicals in food.
We are using our existing resources to access and evaluate these modern methods and tools. We intend to validate and incorporate them into our safety assessments, as additional resources permit.
The FDA is enhancing its approach to food chemical safety in three key areas with corresponding objectives that complement our existing food chemical safety monitoring programs. Additional resources will be necessary for the agency to pursue some of these objectives and will help ensure more steady progress toward our goals.
Expand and Integrate Information Technology (IT) Tools: The FDA’s goal is to develop an integrated information systems approach to monitoring the food supply and food ingredients.
- Develop a new Expanded Decision Tree to prioritize chemicals and substances for evaluation: The FDA will finish development of its Expanded Decision Tree, which is a scientific tool that sorts chemicals into classes of toxicity potential using a series of structure-based questions. The Expanded Decision Tree is a modernized version of the original Cramer Decision Tree tool and can be used to screen chemicals based on their structural features. The updated, expanded and greatly refined questions of the Expanded Decision Tree allow classification of chemicals with greater specificity than the Cramer Decision Tree. It will provide a consistent, systematic and science-based tool to help evaluate the safety of chemicals based on their predicted toxicity.
- Use New Approach Methods (NAMs) such as alternatives to animal toxicology testing: The FDA’s goal is to spur the adoption of reliable and new alternative methods for regulatory use that can replace, reduce and refine animal testing. This will also improve nonclinical testing to streamline the development of products the FDA regulates and bring them to consumers in the U.S. more rapidly and efficiently while ensuring they are safe. The FDA is working to develop a comprehensive strategy to evaluate the potential of new methodologies and technologies for regulatory use in food.
- Establish a framework to systematically review the post-market safety of authorized uses of chemicals in food: The FDA conducts post-market safety reviews of authorized uses of chemicals in food. The framework would be in addition to the safety reviews of submissions already in place and include a transparent process for identifying and prioritizing chemicals for safety reviews.
- Explore how to obtain better information on the post-market use of authorized chemicals from industry and other stakeholders: The FDA generally must rely on post-market information that is submitted voluntarily, which means we often have incomplete information to conduct safety reassessments.
- Refine cumulative exposure procedures: The FDA will work with other experts, including other government agencies, to consider updating and enhancing its approach to assessment of cumulative exposures. This will include how the FDA considers co-occurrence and cumulative exposure of contaminants in food.
- Strengthen the FDA’s compliance activities that evaluate whether industry is meeting its responsibilities under the law and following FDA regulations governing chemicals in food: This includes the requirements for the safe use of chemicals as food ingredients, substances that come into contact with food, and substances that are Generally Recognized as Safe. Separately, the FDA will also reevaluate the oversight activities that address chemicals that occur in food as a result of contamination.
- Enhance surveillance of the food supply: The FDA will expand its ongoing work to address contaminants in food by developing and updating analytical methods, enhancing contaminant-focused surveillance (including sampling), and sharing data and analysis from sampling efforts as appropriate to ensure transparency.
- Enhance detection of emerging chemical safety issues: The FDA will develop a framework for monitoring signals that relate to emerging issues concerning chemicals intentionally added to food as well as contaminants. The FDA will develop a prioritization system and improved capacity for risk assessment, communication and management.
- Develop a systematic approach to assess feasibility and achievability: For greater consistency and transparency in FDA guidance, regulations and enforcement actions related to chemical contaminants, the FDA has established a workgroup to develop a systematic approach to assess feasibility and achievability (for instance, manufacturers’ ability to achieve hypothetical maximum limits of contaminants) and incorporate the assessment into consideration of levels of contaminants in food while maintaining a safe and wholesome food supply.
- Update administrative processes through rulemaking: The FDA will continue to work toward publishing rules updating the administrative processes for the Food Additive Petition, Color Additive Petition and Food Contact Notification programs for increased efficiencies.
As we continue to enhance our approach toward regulating chemicals in food or that come into contact with food, we will also seek additional scientific and other stakeholder perspectives on the activities, processes and tools in these key areas and improved transparency.
- Food Ingredients & Packaging
- Chemical Contaminants & Pesticides
- Toxic Elements in Foods and Foodware
- FDA Total Diet Study
- Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods
- Science & Research