Generally Recognized as Safe (GRAS) Guide for Importers and Manufacturers

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Generally Recognized As Safe
The US FDA designates substances as Generally Recognized as Safe (GRAS) if experts have determined via scientific processes that said substances do not pose any inherent health risks. Substances that are GRAS can be found on the FDA’s Food Additives Status List.

This guide covers what GRAS is, food ingredients that have been sanctioned before the implementation of the Federal Food, Drug, and Cosmetics (FD&C) Act, and which direct and indirect food substances are affirmed as GRAS.

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What is Generally Recognized as Safe (GRAS)?

Generally Recognized as Safe (GRAS) is an FDA designation for substances that experts have concluded to be safe for human consumption, under their intended use.

The FD&C Act stipulates that the phrase “food additive” describes any substance intentionally added to food. Food additives may be deemed to be GRAS if scientific procedures have identified those additives to be as harmless as possible.

A substance should undergo testing using stringent scientific procedures according to the following for it to be generally recognized and approved by the FDA as a safe substance:

a. Sections 201(s) and 409 of the FD&C Act

b. FDA’s regulations in 21 CFR 170.3 and 21 CFR 170.30

However, some food substances that were commonly used in foods before 1958 may also be GRAS based on experience.

Unless qualified experts have deemed and recognized the food additive as safe to use under its intended conditions, the FDA generally has to carry out a pre-market review and consequently approve it before the additive can be placed on the market.

You can learn more about GRAS on the FDA’s website.

Product scope

There are instances when substances are added to foods or food contact materials for various purposes. These substances may likely have undergone scientific processes to determine their safety, only after which the FDA would designate these additives as GRAS.

As such, various foods or food contact materials may contain substances generally recognized as safe. In this section, we list several examples of substances that the FDA has affirmed to be GRAS, in both foods and food contact materials.

Substances GRAS in food contact materials

Several specific substances, affirmed as GRAS, are indirectly added to foods (through food-contact materials). These substances include the following such as:

  • Sulfamic acid
  • Dextrans
  • Formic acid
  • Hydrogenated fish oil

These substances may be found in food contact materials such as:

  • Paper food contact items
  • Cotton and cotton fabric food contact items

Substances GRAS in foods

There are also particular substances, directly added to human food, that has been affirmed as GRAS. We list several of those substances below.

  • Acetic acid
  • Malic acid
  • Ammonium hydroxide
  • Corn gluten

Requirements

The Food Additives Status List classifies additives by alphabetical order. These additives are found in numerous parts of 21 CFR and are specified under the FD&C Act.

The usage of each additive on the list has required limitations, meaning that only a certain amount of these additives can legally be added to food, both directly and indirectly.

Substance restrictions

A wide range of substances that are GRAS does not have any specific numerical restrictions. Even though this may be the case, it is a requirement that the usage of these substances complies with good manufacturing practices.

Some substances which are generally recognized as safe do have quantitative restrictions, such as the following:

a. Sodium benzoate < 0.1% on fruit preservatives

b. Aluminum calcium silicate < 2% by weight on table salt

c. Gum ghatti < 0.2% as emulsifier in non-alcoholic beverages; <0.1% in all other foods

d. Magnesium silicate < 2% in table salt

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) means that manufacturers perform operations in ways that conform to rules ensuring that systems for quality assurance and control are in place and that there exist documentation and records relevant to a finished product’s safety and compliance.

GMP may apply to various additives, even if these are not subjected to a quantitative restriction. Additives that must be handled per good manufacturing practices include those such as the following:

  • Damiana leaves
  • Enzyme-modified soy protein
  • Natural flavoring substances
  • Modified food starch
  • Garlic

GRAS Notification Program

The GRAS Notification Program allows companies to notify the FDA about substances they think are safe per their conditions of use.

Under normal circumstances, substances added to foods should be premarket-approved beforehand by the FDA, unless it is generally recognized by experts as safe. Per the FDA’s regulations, if a company claims a substance is GRAS under the conditions it was intended to be used, and as such not subject to premarket approval, this company may notify the FDA of such a view, by submitting a notice.

Notification process

Companies that submit a GRAS notice to the FDA should do so following the procedures outlined in Subpart E of Part 170 of the FD&C Act. If you are a notifier, the FDA encourages you to contact them about the GRAS notification program, or request a meeting with them to explore potential issues relevant to the submission of a GRAS notice before you make any submissions.

The FDA may respond in one of three ways:

a. They accept the reason for the notifier’s GRAS conclusion

b. They deduce that the submitted notice is not sufficient for it to be concluded as GRAS due to it not having the relevant data and information, or that the provided information calls into question how safe the notified substance is

c. The agency’s response letter expresses that they have, per the notifier’s request, stopped evaluating the submitted GRAS notice

GRAS Notice Inventory

Since 1998, the GRAS Notice Inventory has been providing information about GRAS notices that have been filed annually. The information, which the FDA updates every month, typically includes the following three things:

a. The substance’s name

b. The FDA-assigned file number (GRN No.) on the notice

c. A hyperlink to the FDA’s response letter. The text in the hyperlink also includes the date the FDA sent the letter

Each file number is a hyperlink to additional information, such as the following:

a. The notifier’s name and address

b. The substance’s intended conditions of use

c. The statutory reason for the GRAS conclusion

d. The date on which FDA files the GRAS notice

e. A hyperlink to other letters that FDA has sent with regard to the GRAS notice

f. A petition number, but only if the substance in the notice was highlighted in a GRAS petition

g. A hyperlink to the GRAS notice

21 CFR 181 – Prior Sanctioned Food Ingredients

Under normal circumstances, substances that are added to food on purpose are considered to be food additives. However, 21 CFR Part 181 provides a list of food or food packaging ingredients that have been previously sanctioned and as such, are not classified as a food additive. This means that they are exempt from the food additive provisions.

A prior sanction for a food ingredient should only exist if the FDA or the USDA has explicitly approved it before September 6, 1958.

Requirements

Prior sanctioned food ingredients should bear characteristics such as:

a. Being of good commercial grade

b. Being acceptable for association with food

c. Being compliant with good manufacturing practice

Prior sanctioned substances used in food packaging materials that end up becoming a part of the food should comply with the following three rules:

a. The substances should not negatively affect or enhance the food in any way

b. There should be as little substance that migrates from the food packaging material in the food as possible

c. The quantity of substance in the food should not exceed the limits stated in 21 CFR Part 181

For example, stannous stearate is a stabilizer that should not exceed a migration of 50 parts per million (ppm) tin in finished food.

Substance examples

21 CFR Part 181 provides multiple substances and food ingredients that are used in the manufacture of food-contact packaging material, and that has been prior sanctioned. We provide several examples below.

Antimycotics

  • Calcium propionate
  • Sorbic acid

Antioxidants

  • Gum guaiac
  • Propyl gallate

Driers

  • Cobalt linoleate
  • Manganese tallate

Plasticizers

  • Acetyl tributyl citrate
  • Acetyl triethyl citrate

Stabilizers

  • Ammonium citrate
  • Magnesium phosphate

21 CFR 182 – Substances Generally Recognized as Safe

21 CFR Part 182 notes the impossibility and impracticality of listing every single substance that experts have generally recognized as being safe enough to include in food and food-contact packaging materials.

Regardless, it does cover a wide range of substances that are GRAS when used in a manner that is in line with good manufacturing practices.

Requirements

Substances that are generally recognized as safe and are used per good manufacturing practices should conform to restrictions, such as the following:

a. The amount of substances that are added to food should not exceed what is reasonably necessary to enhance the food’s flavor, look, or nutrition

b. The amount of substances that end up in food as a result of it being included in the material of food-contact packaging material during its manufacture should have as little effect on the food as possible

c. The substances should be of a suitable food grade

Substance examples

Several substances, which are GRAS, may migrate from cotton and cotton fabrics that are used to package dry food. Examples of such substances include the following:

  • Beef tallow
  • Peanut oil
  • Sodium acetate
  • Tapioca starch
  • Zinc chloride

Paper and paperboard products that are used in food packaging and food contact materials may contain substances that are generally recognized as safe, such as the following:

  • Aluminum
  • Cornstarch
  • Glycerin
  • Sorbitol
  • Talc

21 CFR 184 – Direct Food Substances Affirmed as GRAS

21 CFR Part 184 covers multiple substances that are directly added to food. The FDA has reviewed and affirmed these substances to be generally recognized as safe for use under the intended conditions.

Requirements

Substances directly used in food, not in food contact materials, that are confirmed to be GRAS should be used in ways that line up with good manufacturing practice, which includes requirements such as:

a. The substance is to be of an appropriate food grade

b. The substance is to be prepared and handled as one does with a food ingredient

c. The amount of substance that has been added directly to the food should not be more than what is logically needed to make the food look and feel better or more nutritional

Labeling requirements

The FDA requires that the packaging of ingredients to be used in finished food must be labeled appropriately. The label should bear information such as the following:

a. The ingredient’s name

b. A statement specifying the concentration of the substance in any intermediate mixture (or a piece of information that an independent food processor can use to ascertain whether the substances in the mixture conform to good manufacturing practice and any limitations therein)

c. Acceptable instructions for providing a final food product that shows compliance with the restrictions set for the substances within

Substance examples

Among the extensive list of substances that are affirmed to be GRAS and directly added to food are examples such as the following:

  • Citric acid
  • Red algae
  • n-Butane and iso-butane
  • Ethyl alcohol
  • Guar gum
  • Helium

21 CFR 186 – Indirect Food Substances Affirmed as GRAS

21 CFR Part 186 covers ingredients and substances that are indirectly added to food, via migration from food contact materials. The FDA has reviewed and affirmed these substances as generally recognized as safe to be used the way they were intended.

Requirements

Ingredients that are affirmed as GRAS, and authorized, by the FDA are required to be used per GMP when these ingredients might indirectly migrate from their immediate container, food contact material, or wrapper.

Substance examples

Substances affirmed by the FDA as GRAS that may be indirectly added to food via food contact materials such as food packaging include the following:

  • Ferric oxide
  • Iron oxide
  • Japan wax
  • Pulp
  • Sodium formate
  • Sorbose
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