GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) regulates approximately 80% of the US food supply. The Food and Drug Administration is also responsible for reviewing the food product’s packaging along with its ingredients. There are ingredients that do not change the food product’s taste or makeup and are present for reasons such as shelf preservation, color and aroma. These added ingredients are classified Generally Recognized As Safe (GRAS). Industrial gases that are utilized in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration are classified as such.


In 1958 Congress enacted 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 which are not considered additives and are considered GRAS.

In the late 60’s cyclamate salts, which were used as an artificial sweetener for sodas and classified as GRAS, began to be questioned. The results incited then President Nixon to call on the FDA to reexamine all substances classified as GRAS. In 1997, the FDA claimed that they did not have adequate resources to fulfill all the insistence that they were receiving for substances to be classified.

Since then, previous substances that were considered GRAS were upholding 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 decided by individual experts outside the government. In simpler terms, a GRAS classification prior to 1997 was sanctioned by the FDA and following 1997 by consensus of recognized experts then quickly audited by the FDA.

How does this apply to gases used in MAP?

The essential point to take away is that there is no federal certification granted to industrial gases utilized for food processing be it freezing, formulation or packaging. The gases that are given the classification of GRAS are carbon dioxide, helium, nitrogen, nitrous oxide and propane. The Code of Federal Regulations section 184.1 explains 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 mentioned, gas suppliers are only responsible for the purity of the gas product and the other sanctions (i.e. … adequate manufacturing practices…) are goverened by the food processor or the gas supplier’s customer.

Additionally, hydrogen, carbon monoxide and argon were acknowledged as ingredients after 1997 and are not listed in 21 CFR. Since then, they 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 important fact to take from this article is that the any gases labeled “Food Grade” have been certified in house by the manufacturer and not by the FDA. The certification is by purity defined by best practice in the manufacture and handling of the product to its final package (cylinders, micro-bulk vessels, transports and large cryogenic vessels). Food processors have been conditioned to keep an eye out for food grade products and want to see clean packages with clear labels. So having dedicated “food grade” cylinders and/or tanks is necessary to succeed in this market as is proven by the dominant 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 are in search of food grade gases or other specialty gases for various industries in Beaumont, contact Coastal Welding Supply at 800-852-4177 or contact us via email at

Written by John Segura.

John Segura is a licensed Professional Engineer and a well-rounded 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 been a leader to teams of engineers and technicians as an R & D manager for major gas companies. His work eventually led him to lead the marketing efforts of technology worldwide for industrial gas suppliers. He now consults to the industry on the business specializing in operations, applications and marketing.