How Does Food Additives Manufacturer Work?

The Federal Food, Drug, and Cosmetic Act defines different types of food ingredients based on how they are intended to be used and the FDA’s authorities related to them. Working within these authorities, the FDA administers separate programs for uses of ingredients that are food additives and generally recognized as safe (GRAS).

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Ingredients that are Food Additives

Some ingredients are food additives. A food additive is defined in the Federal Food, Drug, and Cosmetic Act as any substance the intended use of which results or may reasonably be expected to result – directly or indirectly – in it becoming a component or otherwise affecting the characteristics of any food.

The following are not included in the definition of a food additive:

• Ingredients that are generally recognized as safe (GRAS).
• Prior-sanctioned substances – are substances authorized for use by the FDA or the U.S. Department of Agriculture prior to the Food Additives Amendment. Examples include sodium nitrite and potassium nitrite used to preserve luncheon meats.
• Color additives and pesticides where other legal pre-market approval requirements apply.
• Dietary ingredients in dietary supplements.

The following information on this page is about direct food additives.

Direct food additives are those that are added to a food for a specific purpose. For example, xanthan gum – used in salad dressings, chocolate milk, bakery fillings, puddings and other foods – is a direct additive used to add texture. Most direct additives are identified on the ingredient label of foods.

Under the Federal Food, Drug, and Cosmetic Act, a food additive must be authorized by the FDA before it can be used in food on the market. A manufacturer or other sponsor must first seek approval from the FDA by submitting a food additive petition to market a new direct food additive or before using a direct food additive in a different way than how the FDA has currently approved it. The FDA consults with U.S. Department of Agriculture during the review process for food additives that are proposed for use in meat and poultry products.

Food additive petitions must provide evidence that the substance is safe for the ways in which it will be used – including the foods it will be used in and the intended levels of use. We have guidance documents available on the FDA's website, including Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives, that assist manufacturers with submitting a petition.

The FDA publishes a notice of the petitions under FDA review in the public Federal Register. The FDA evaluates the petition, and other available data and information to determine if the data demonstrate that the food additive is safe under the proposed conditions of use. The safety of food additives must be supported by science that demonstrates its use meets the FDA’s safety standard – a reasonable certainty of no harm.

When evaluating the safety of an ingredient submitted in a food additive petition, the FDA considers:

• What is the food ingredient?
• How will the food ingredient be made?
• How much of the ingredient will be in food?
• What types of foods will the ingredient be used in?
• How much of the food ingredient will consumers eat?
• How does the body metabolize the food ingredient (including absorption, digestion, metabolism, and excretion)?
• What are the results of relevant scientific studies on the safety of the ingredient?

The FDA determines an Acceptable Daily Intake or the amount of a substance considered safe to consume each day over the course of a person’s lifetime. This level includes built in a safety margin that includes factors accounting for potential uncertainties in the data and known variability within the population and vulnerable populations, such as people who are pregnant and children. We also consider expected exposure for consumers who eat the average amount of foods containing the food additive and for consumers who eat much more than the average amount of foods containing the food additive. These approaches ensure that the consumption of an additive from an approved use is much lower than what would be expected to have any adverse effect.

For every food additive the FDA approves, the agency issues a regulation that authorizes uses of the food additive that meet the safety standard for food use. The food additive regulations are in the U.S. Code of Federal Regulations (CFR). These regulations may specify the types of foods in which the food additive can be used, the maximum amounts to be used in those foods, and how it should be identified on food labels. Manufacturers are also required to limit the amount of food additives to the amount necessary to achieve the desired effect.

The FDA manages and maintains a public inventory where we list all of the food additive petitions under active FDA review or that are filed but not active because deficiencies were identified during the FDA’s review.

Ingredients that are Generally Recognized as Safe (GRAS)

The definition of food additive in the Federal Food, Drug, and Cosmetic Act includes a provision for the uses of ingredients that are Generally Recognized as Safe (GRAS). As such, these ingredients do not require pre-market review by the FDA. For the use of an ingredient 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. Some examples of GRAS ingredients include canola oil, vinegar, and spices such as black pepper.

Any person, typically a food or ingredient manufacturer, that has concluded that the use of an ingredient can meet the standard for GRAS may notify the FDA through the FDA’s GRAS Notification Program. The FDA has established a GRAS Notification Program to help ensure that these ingredients are safe for the ways in which they will be used and to help industry meet its responsibility for ensuring the GRAS status of ingredients they intend to use in food. This notification is not mandatory; however, the FDA strongly encourages manufacturers to contact the agency and follow the available procedures for our oversight of GRAS conclusions by submitting a GRAS notice. The FDA also assists the food industry through our regulations and guidance documents.

When the FDA evaluates a GRAS Notice, the agency considers whether the notice demonstrates that the ingredient is safe under the conditions of its intended use and whether the criteria for general recognition are satisfied. When evaluating the use of a GRAS ingredient, the FDA considers all relevant and reliable information to understand:

• What is the food ingredient?
• How will the food ingredient be made?
• How much of the ingredient will be in food?
• What types of foods will the ingredient be used in?
• How much of the food ingredient will consumers eat?
• How does the body metabolize the food ingredient (including absorption, digestion, metabolism, and excretion)?
• What are the results of relevant scientific studies on the safety of the ingredient?

The FDA consults with U.S. Department of Agriculture during the review process for GRAS notices for ingredients that are proposed for use in meat and poultry products.

Following this evaluation, the FDA responds to the manufacturer with a letter describing whether we question the basis for the manufacturer’s GRAS conclusion. 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 FDA’s final response letters to manufacturers are available to the public. Manufacturers that choose not to go through the FDA’s GRAS Notification program are still responsible to produce products that are compliant with the law.

Post-market Assessment Related to Food Ingredients

The FDA stays abreast of the latest science available about food additives and GRAS ingredients in a variety of ways. We participate in international scientific and standard setting activities related to food ingredient safety such as the Codex Alimentarius Commission and the Joint FAO/WHO Expert Committee on Food Additives, attend scientific conferences, and engage other public health and research stakeholders. These activities help us stay informed about the safety and exposure of food additives in scientific literature and released by other agencies.

FDA scientists also assess the science about the exposure and safety of a food ingredient each time we file a food additive petition or review a GRAS notice. Additionally, we may proactively choose to assess a food additive or GRAS ingredient in food when new information about its safety profile warrants assessment. The FDA has strict data requirements that must be met to establish safe conditions of use during review of a pre-market submission, and as new scientific information becomes available, we may re-evaluate the safety assessments. This includes reviewing published scientific literature and studies from other regulatory and health agencies in the U.S. and in other countries, and updated information when the same substance is the subject of a new submission. In some of our assessments, we identify areas where additional information is needed. We may work with research partners on studies to help fill these data gaps. We are exploring how to obtain better information on the post-market use of food ingredients from industry and other stakeholders.

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If after the FDA’s assessment of a food additive or GRAS ingredient we have determined its use meets our safety standard, the regulatory status of the food additive or GRAS ingredient would remain unchanged. If after the FDA’s assessment of a food additive or GRAS ingredient, we have determined its use does not meet our safety standard, the agency can take various actions to protect public health. These actions include issuing a public warning letter to companies that manufacture or distribute the food ingredient and/or food containing the food ingredient, issuing a public alert, and taking enforcement action to stop distribution of the food ingredient and foods containing it on the grounds that such foods are or contain an unapproved food additive. Some changes can take time such as revoking a food additive approval because we are required to follow certain regulatory processes, such as providing an opportunity for public comment. Some recent examples include the agency’s work to remove trans fat and warn companies marketing Cannabidiol (CBD) and Delta-8 THC products:

• Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)
• FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

Key facts

• Food additives are substances primarily added to processed foods, or other foods produced on an industrial scale, for technical purposes, e.g. to improve safety, increase the amount of time a food can be stored, or modify sensory properties of food.
• Food additives are substances not normally consumed as a food by themselves and not normally used as typical ingredients in foods. Most minimally processed and unprocessed foods do not contain food additives.
• Food additives are assessed for potential harmful effects on human health before they are approved for use.
• Authoritative bodies at the national, regional and international levels are responsible for evaluating the safety of food additives.
• The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is the international body responsible for evaluating the safety of food additives for use in foods that are traded internationally.

Overview

Many different food additives have been developed over time to meet the needs of large-scale food processing. Additives are added to ensure processed food remains safe and in good condition throughout its journey from factories or industrial kitchens, to warehouses and shops, and finally to consumers. Additives are also used to modify the sensory properties of foods including taste, smell, texture and appearance. 

Food additives can be derived from plants, animals or minerals, or they can be chemically synthesized. There are several thousand food additives used, all of which are designed to do a specific job. Food additives can be grouped into 3 broad categories based on their function.

Flavouring agents

Flavouring agents are chemicals that impart flavours or fragrances and are added to food to modify its aroma or taste. They are the most common type of additive used in foods, with hundreds of varieties used in a wide variety of foods, from confectionery and soft drinks to cereal, cake and yoghurt. Flavouring agents can be extracted from naturally occurring sources (e.g. plant or animal sources) or chemically synthesized. Flavours extracted directly from naturally occurring sources are often referred to as natural flavours. Such flavours can also be chemically synthesized and are sometimes referred to as nature made or nature identical to indicate that although the flavour molecule itself is naturally occurring it hasn’t been extracted from its source, but synthesized to be identical. Artificial flavouring agents are chemicals that do not exist in nature but are synthesized to imitate natural flavours or elicit other taste sensations. Culinary ingredients, including spices, nuts and dried fruits or vegetables, can also modify aroma or taste, but are generally not considered flavouring agents.

Enzyme preparations

Enzyme preparations are a type of additive that may or may not end up in the final food product. Enzymes are naturally occurring proteins that boost biochemical reactions by breaking down larger molecules into their smaller building blocks. They can be obtained by extraction from plants or animal products or from micro-organisms such as bacteria and are used as alternatives to chemical-based technology. They are mainly used in baking (to improve the dough), for manufacturing fruit juices (to increase yields), in wine making and brewing (to improve fermentation), as well as in cheese manufacturing (to improve curd formation).

Other additives

Other food additives are used for a variety of reasons, such as preservation, colouring and sweetening. They are added when food is prepared, packaged, transported, or stored, and they eventually become a component of the food.

Preservatives can slow decomposition caused by mould, air, bacteria or yeast. In addition to maintaining the quality of the food, preservatives help control contamination that can cause foodborne illness, including life-threatening botulism.

Colouring is added to food to replace colours lost during processing or other production, or to make food appear more attractive.

Non-sugar sweeteners are often used as an alternative to sugar because they contribute fewer or no calories when added to food. WHO has issued a recommendation against the use of non-sugar sweeteners in general, based on evidence that they don’t seem to benefit long term weight loss or maintenance and may increase risk of noncommunicable diseases.

Safety assessments

Food additives are assessed for potential harmful effects on human health before they are approved for use. Authoritative bodies at the national, regional and international levels are responsible for evaluating the safety of food additives. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is the international body responsible for evaluating the safety of food additives for use in foods that are traded internationally.

WHO response

Evaluating the health risk of food additives

WHO, in cooperation with the Food and Agriculture Organization of the United Nations (FAO), is responsible for assessing the risks to human health from food additives. Risk assessments of food additives are conducted by an independent, international expert scientific group – the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Only food additives that have undergone a JECFA safety assessment and are found not to present an appreciable health risk to consumers can be used internationally. This applies whether food additives come from natural sources or they are synthetic. National authorities, either based on the JECFA assessment or a national assessment, can then authorize the use of food additives at specified levels for specific foods.

JECFA evaluations are based on scientific reviews of all available biochemical, toxicological, and other relevant data on a given additive – mandatory tests in animals, research studies and observations in humans are considered. The toxicological tests required by JECFA include acute, short-term and long-term studies that determine how the food additive is absorbed, distributed and excreted, and possible harmful effects of the additive or its by-products at certain exposure levels.

The starting point for determining whether a food additive can be used without having harmful effects is to establish the acceptable daily intake (ADI). The ADI is an estimate of the amount of an additive in food or drinking water that can be safely consumed daily over a lifetime without adverse health effects.

International standards for the safe use of food additives

The safety assessments completed by JECFA are used by the joint intergovernmental food standard-setting body of FAO and WHO, the Codex Alimentarius Commission, to establish levels for maximum use of additives in food and drinks. Codex standards are the reference for national standards for consumer protection, and for the international trade in food, so that consumers everywhere can be confident that the food they eat meets the agreed standards for safety and quality, no matter where it was produced.

Once a food additive has been found to be safe for use by JECFA and maximum use levels have been established in the Codex General Standard for Food Additives, national food regulations need to be implemented permitting the actual use of a food additive.

How do I know which additives are in my food?

The Codex Alimentarius Commission also establishes standards and guidelines on food labelling. These standards are implemented in most countries, and food manufacturers are obliged to indicate which additives are in their products. In the European Union, for example, there is legislation governing labelling of food additives according to a set of pre-defined E-numbers. People who have allergies or sensitivities to certain food additives should check labels carefully.

WHO encourages national authorities to monitor and ensure that food additives in food and drinks produced in their countries comply with permitted uses, conditions and legislation. National authorities should oversee the food business, which carries the primary responsibility for ensuring that the use of a food additive is safe and complies with legislation.

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