On June 18, , the FDA released for public comment its proposed method for ranking chemicals in the food supply to determine which chemicals the agency would prioritize for post-market assessment through the agency’s post-market chemical review program. The FDA encourages the public to comment in docket FDA--N- in response to the questions listed in Section 4 of the method description document. The last day to submit comments on the method is July 18, . This is one effort under FDA’s broader initiative to advance a robust, transparent post-market chemical review program to keep the American food supply safe.
TJCY are exported all over the world and different industries with quality first. Our belief is to provide our customers with more and better high value-added products. Let's create a better future together.
Key Points:
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.
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:
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:
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.
The FDA has established tolerances, action levels, and guidance levels for some contaminants in food. A consolidated list of existing contaminant levels in food is available at Chemical Contaminants Transparency Tool.
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.
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:
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.
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:
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.
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. 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:
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.
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 toxic 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 structure and predicted toxic potential.
In March , the FDA submitted the Expanded Decision Tree to external peer-review as a step toward validating the tool. This peer review will collect input from the external scientific experts in line with the requirements of the Information Quality Act. Once the peer review is complete, the FDA plans to make the peer review report, and a white paper describing the Expanded Decision Tree, available to the public for additional feedback.
Establish a framework to systematically review the post-market safety 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.
On September 25, , the FDA hosted a public meeting on the Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food. The purpose of this meeting was for the FDA to share information about the development of the FDA’s enhanced systematic process for post-market assessment of chemicals in food, including considerations for identifying and prioritizing food chemicals currently in the market for safety reviews. In addition, industry and consumer advocacy experts, government officials, research organizations, and other stakeholders had the opportunity to learn more, ask questions, and provide open public comment to address specific questions posed by the FDA. We invite those interested to provide information on topics related to the systematic process outlined in the discussion paper and welcome feedback on the following questions. Electronic comments must be submitted to the docket FDA--N- on or before December 6, .
Read about our FY priorities for food chemical safety: Human Food Program (HFP) FY Priority Deliverables.
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.