GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) controls about 80% of the US food supply. The FDA is likewise in charge of inspecting not only the ingredients of the food product but the packaging as well. Several ingredients that do not affect the food product’s taste or makeup and are present for reasons such as shelf preservation, color and aroma. These ingredients are classified Generally Recognized As Safe (GRAS). Industrial gases that are used in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration are classified into this category.


In 1958 Congress implemented the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. One item included in the amendment was the definition of food additive:

“Any substance the intended use for which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the component of food.”

Excluded are like gas mixtures that are classified as additives and not considered GRAS.

In the late 60’s cyclamate salts, which were utilized as an artificial sweetener in soft drinks and grouped as GRAS, began to be questioned. The conclusion urged then President Nixon to call on the FDA to reevalute the components that were considered GRAS. In 1997, the FDA claimed that they did not have adequate resources to address all the insistence that they were receiving for substances to be classified.

Since then, the materials that were originally considered GRAS were keeping their classification and can be found in the Code of Federal Regulations (21 CFR). All substances requesting classification after 1997 were given a GRAS Notice which is determined by individual authorities outside the government. In simpler terms, a GRAS classification before 1997 was sanctioned by the FDA and following 1997 by agreement of recognized experts then briefly audited by the FDA.

How does this apply to gases used in MAP?

The main objective to keep in mind is that there is no federal certification given to industrial gases utilized for food processing be it freezing, formulation or packaging. The gases that are classified as GRAS are carbon dioxide, helium, nitrogen, nitrous oxide and propane. The Code of Federal Regulations section 184.1 describes each of these gases, with respect to suitability, with the same phrasing. This, in part, is:

· The ingredient must be of a purity suitable for its intended use.

· In accordance with 184.1--- (last three numbers identify the gas), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing conditions of use:

o The ingredient is used in food at levels not to exceed current good manufacturing practice.

o Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.”

As declared above, gas suppliers are only responsible for the purity of the product and the other sanctions (i.e. … proper manufacturing practices…) are controlled by the food processor or the gas supplier’s customer.

In addition, hydrogen, carbon monoxide and argon were acknowledged as ingredients after 1997 and are not listed in 21 CFR. They have since that time been given a GRAS Notice under the heading of “No Questions” which indicates that the FDA had no questions as to the accuracy of the outside expert’s consensus.

The crucial point to learn from this is that the any gases considered “Food Grade” have been certified in house by the manufacturer rather than by the FDA. The certification is by purity defined by proper handling and manufacturing of the final product until it reaches its final package (cylinders, micro-bulk vessels, transports and large cryogenic vessels). Food processors are trained to search for food grade products and like to see clean packages with clear labels. So having dedicated “food grade” cylinders and/or tanks is important to service this market as is evidenced by the successful companies naming and trademarking their respective lines of food grade gases.

Further information on food grade gases and MAP applications can be found through PurityPlus. If you’re interested in purchasing food grade gases or other specialty gases for various industries in Indianapolis, contact American Welding & Gas, Inc. at or contact us via email at

Written by John Segura.

John Segura is a licensed Professional Engineer and a seasoned executive in the industrial gas industry. He has 30+ years of experience in areas involving sales, marketing, and operations both domestically and internationally. He has led teams of engineers and technicians as an R & D manager for major gas companies. His work guided him to be the leader of the marketing efforts of technology worldwide for industrial gas suppliers. He currently consults to the industry on the business specializing in operations, applications and marketing.