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  1. Food Ingredients & Packaging

Food Chemical Safety

Food Chemical Safety

 

Key Points:

  • The FDA ensures exposure to chemicals in food is safe. This includes chemicals authorized for use in and with foods during food packaging, processing, or other handling, or contaminants that enter the food supply through the growing or processing environment.
  • Food manufacturers also have a major role in food chemical safety. The food industry has a responsibility to minimize or prevent hazards from contaminants and ensure the safety of chemicals they use.
  • Our Office of Food Chemical Safety, Dietary Supplements & Innovation houses our programs for food chemical safety, dietary supplements, and foods made using innovative technologies. Under the Human Foods Program, we are leveraging our scientific expertise across these product areas and developing a more nimble and systematic approach to evaluating chemicals in the food supply.

Pre-Market Activities | Post-Market Activities | Evaluating Food Chemical Safety | Modern Methods and Tools | Enhanced Approach | Related FDA Programs | Announcements | Consumer Education

Chemicals are used in food during food production and in food packaging for useful purposes, such as preserving quality, adding nutritional value, extending shelf life, and protecting food from pathogens that can 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 byproducts, can form during food processing, especially when heating (cooking), drying or fermenting foods.

The FDA protects consumers from harmful exposure to chemicals that are in foods through a comprehensive, science-driven, and modernized approach. The work of the agency is coordinated by the Human Foods Program’s Office of Food Chemical Safety, Dietary Supplements & Innovation.

The FDA helps to safeguard the food supply through pre-market and post-market safety evaluations of chemicals as food ingredients and in 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 ensures that industry is preventing when possible, and mitigating when prevention is not possible, unsafe exposure from chemical contaminants that can enter the food supply through the growing and processing environment. The agency 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.

Food manufacturers are responsible for marketing safe foods. The food industry has a responsibility to ensure the safety of the foods they grow, make, and sell. For chemicals that are intentionally added to foods or food contact materials, they must ensure exposure to the chemical in the food or food contact substance is safe and that they have met all necessary requirements. Additionally, food manufacturers have a responsibility to implement current good manufacturing practices and preventive controls as needed to significantly minimize or prevent exposure to contaminants.

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.

Pre-Market Activities

Our pre-market programs are critical to helping prevent unsafe uses of chemicals and help ensure that innovative approaches in manufacturing food ingredients and packaging result in safe food products.

Food additives and color additives must be authorized for their use in food before they enter the market. To obtain a new authorization, a manufacturer is required to submit information to the FDA that demonstrates the food or color additive use meets the applicable 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 a food additive in the Federal Food, Drug, and Cosmetic Act, which is the law governing food additives as amended by Congress in 1958, excludes the uses of ingredients that are Generally Recognized as Safe (GRAS). This provision does not  explicitly grant the FDA the ability to require pre-market GRAS submissions. The FDA has established a voluntary GRAS notification program to help ensure that these ingredients 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. 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 manages and maintains a public inventory where all GRAS notices that have been filed by the agency, along with the supporting data, and the FDA’s final response letters to manufacturers are available. Manufacturers that choose not to go through the FDA’s GRAS Notification program are still responsible to produce safe products that comply with the law.

Post-Market Activities

The FDA is engaged in various post-market activities on an ongoing basis to help ensure exposure to chemicals used as food ingredients and substances that come into contact with food is safe. We also help limit exposure to contaminants that may be unsafe by monitoring the food supply for contaminants, contributing to research to enhance detection methods, and engaging with manufacturers on implementing controls to prevent and minimize contaminants in food before they are on the market. 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 reviews new scientific information and research on contaminants in foods that can enter the food supply through the growing and processing environment. The FDA monitors contaminant levels in foods, establishes regulations as needed, and provides guidance to food manufacturers on how to meet their legal obligation to implement current good manufacturing practices and preventive controls as needed to significantly minimize or prevent hazards from contaminants in foods and food contact materials (such as cookware and packaging). The FDA also partners with other U.S. and international regulatory agencies on monitoring and regulatory activities for contaminants. The FDA is partnering with the USDA to collaborate with growers to reduce levels of lead, cadmium, arsenic, and mercury across commodities used in foods intended for babies and young children through our Closer to Zero initiative. The FDA monitors the food supply by testing both domestic and imported foods through several different programs, including the FDA’s compliance programs for toxic elements and mycotoxins. In addition, 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.
  • Enforcing Compliance with Pesticide Tolerances: Pesticides are used in agriculture to protect crops from insects, fungi, weeds and other pests. The U.S. Environmental Protection Agency (EPA) evaluates pesticides to ensure that they are safe for human health and the environment and establishes tolerances, which are the maximum residue level of a specific pesticide chemical that is permitted in or on a specific human or animal food in the U.S. The FDA is responsible for enforcing the EPA tolerances for domestic foods shipped in interstate commerce and foods offered for import into the U.S., except for meat, poultry, catfish (Siluriformes) and certain egg products that are regulated by the U.S. Department of Agriculture’s Food Safety and Inspection Service.
  • 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 to 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 on identifying ways to prevent or minimize exposure as much as possible. For example, as part of our technical assistance to states, the FDA is contributing to research to understand how per- and polyfluoroalkyl substances (PFAS) are taken up by plants and how PFAS concentrations vary between plants and parts of a plant. This is an area of research that may help us make significant reductions in PFAS exposure from food.
  • 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. We engage manufacturers on implementing controls for potential hazards from contaminants in food and on meeting their responsibilities under the provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.

As science evolves, the agency’s active post-market monitoring of food chemical safety information informs our post-market assessments. To increase transparency of our post-market assessments, we maintain a public list of chemicals under FDA review with information about the steps in our risk review process. As part of our collection of food ingredient and packaging inventories, the FDA maintains a Post-market Determinations inventory that includes memos documenting the FDA’s determination that the use of an ingredient in the food supply that does not meet the criteria for the GRAS.

Evaluating Food Chemical Safety

The FDA evaluates the safety of chemicals in food (both intentionally added and contaminants) and chemicals 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 in food ingredients, packaging, cell culture and plant biotechnology, 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 further research would be beneficial. 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 Exposure to 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 Food Additives and GRAS Ingredients Information for Consumers.

Evaluating the Safety of Exposure to 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.

Modern Methods and Tools

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. An essential aspect of this work is that we have access to all available data about chemicals in the food supply, 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.

Enhanced Approach

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.

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.

Related FDA Programs

Announcements

Consumer Education

 



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