Food Safety & Regulation

National authorities are responsible for establishing the safety of food additives and implementing regulations prescribing their safe use. For countries that don&#;t have the resources or infrastructure to develop their own safety evaluations and regulations, the Joint Food and Agriculture Organization (FAO) / World Health Organization (WHO) Food Standards Programme, known as the Codex Alimentarius, develops harmonized, voluntary, international food standards utilizing a transparent, science-based process to ensure food safety and quality, as well as fair trade.

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Codex work is conducted primarily through a committee structure, and food additives are addressed through the Codex Committee on Food Additives (CCFA). The Joint FAO/WHO Expert Committee on Food Additives, abbreviated JECFA, is an international scientific body that evaluates and determines the safety of food additives prior to entering the Codex process. JECFA works in several key areas: risk assessment and safety evaluation of food additives, processing aids, flavorings, residues of veterinary drugs in animal products, contaminants, and natural toxins; exposure assessments; specifications and analytical methods; and development of general principles. JECFA holds meetings throughout the year to focus on specific work areas, and brings together experts from around the world to conduct its business.

With regard to food additives, JECFA reviews the safety of an additive or group of additives, and based on available safety data develops a specification, which includes such information as a description of the additive, its functional uses in food, identity and purity characteristics, and tests used to characterize the additive. A JECFA specification monograph is finalized and published for each additive or group of additives. Importantly, the monograph includes information about the additive&#;s &#;acceptable daily intake level&#; or ADI, which is the amount of the substance that can be ingested on a daily basis over the course of a lifetime and not result in an appreciable health risk. ADIs are calculated in milligrams per kilogram, body weight per day, and are extremely conservative to take into account sub-populations, including pregnant and lactating women, children, and the elderly.

In order for a food additive to be recognized within CCFA, it must be listed in the General Standard for Food Additives (GSFA). The GSFA establishes conditions under which additives may be used in foods, and notes those food categories and use levels for which food additives may be used. To be listed in the GSFA, an additive must have a JECFA specification monograph confirming its safety, as well as an INS number. The Codex International Numbering System (INS) is similar to the &#;E number&#; system in Europe, whereby each additive or group of additives is assigned a specific number for the purpose of identifying the additive globally on ingredient lists. To learn more about Codex and its many committees, click here.

For centuries, ingredients in food have served a variety of useful functions. Our ancestors used salt to preserve meats and fish, added herbs and spices to improve the flavor of foods, preserved fruit with sugar, and pickled vegetables in vinegar solutions. Many ingredients help ensure the availability of flavorful, nutritious, safe, convenient, and affordable foods that meet consumer expectations year-round.

Ingredients are added to foods for a variety of functions, such as:

• Maintain or Improve Safety and Freshness: Preservatives slow product spoilage caused by mold, air, bacteria, fungi or yeast. In addition to maintaining the quality of the food, they help control contamination that can cause foodborne illness, including life-threatening botulism. One group of preservatives -- antioxidants -- prevents fats and oils and the foods containing them from becoming rancid or developing an off-flavor. They also prevent cut fresh fruits such as apples from turning brown when exposed to air.
• Improve or Maintain Nutritional Value: Nutrients such as vitamins and minerals are added to many foods to make up for those lacking in a person's diet or lost in processing, or to enhance the nutritional quality of a food.
• Improve Taste and Texture: Spices, natural and artificial flavors, and sweeteners are added to enhance the taste of foods. Emulsifiers, stabilizers and thickeners give foods the texture and consistency consumers expect. Leavening agents allow baked goods to rise during baking. Some additives help control the acidity and alkalinity of foods, while other ingredients help maintain the taste and appeal of foods with reduced fat content.

In general, all ingredients must be declared on food labels, unless there is an exemption. Food manufacturers are responsible for marketing safe foods, including ensuring the safety and regulatory status of the ingredients they use in foods before they are available to consumers. The FDA evaluates and regulates ingredients added to food to help ensure they are used safely. 

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The safety of food additives and ingredients that are generally recognized as safe (GRAS) must be supported by science that demonstrates its use meets the FDA&#;s safety standard. Specifically, the information must demonstrate that there is a reasonable certainty of no harm to consumers when an ingredient is proposed or intended for use in food. Because of inherent limitations of science, the FDA can never be absolutely certain of the absence of any risk from the use of any ingredient.

The FDA has several programs as part of its oversight over food ingredients and to aid the food industry in complying with the law. As part of the FDA&#;s programs, the food industry provides information about an ingredient&#;s safety in the appropriate submission to the agency.

Our scientists continue to keep up to date as new research is published and to evaluate whether the new information changes our position on the safety of a food ingredient. 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.

Learn more about how the FDA regulates food additives and uses of ingredients that are GRAS, on Understanding How the FDA Regulates Food Additives and GRAS Ingredients.

The FDA has web pages about specific ingredients, products, or public health initiatives of interest:

The FDA Monitors Reports or Problems Related to Food Products

If you think that you experienced an adverse reaction to a food, including an ingredient, you can report the reaction to the FDA. To report a complaint or adverse event (illness or serious allergic reaction), visit Industry and Consumer Assistance.

If you are a member of the food industry who needs to submit a Reportable Food Registry report when there is a reasonable probability that an article of food will cause serious adverse health consequences or death to humans or animals, please visit the&#;Reportable Food Registry&#;page.

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