GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) regulates about 80% of the US food supply. The administration is likewise in charge of reviewing not only the ingredients of the food product but the packaging as well. There exist ingredients that do not change the food product’s taste or makeup and exist because they affect components of the product 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 implemented the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. One of the items that the amendment covered was the definition of a Food Additive which was:

“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.”

Not included are like gas mixtures which are not considered additives and are considered GRAS.

In the late 60’s cyclamate salts, which were utilized to artificially sweeten soft drinks and considered GRAS, began to be reconsidered. The conclusion prompted then President Nixon to order the FDA to reconsider all substances that fit the GRAS classification. In 1997, the FDA claimed that they did not have adequate resources to fulfill all the demands that they were receiving for substances to be classified.

Since then, the materials that were originally considered GRAS were upholding their classification and can be found in the Code of Federal Regulations (21 CFR). All substances after 1997 requesting classification are granted a GRAS Notice which is concluded by individual experts outside the government. Simply put, a GRAS classification prior to 1997 was sanctioned by the FDA and after 1997 by accord of recognized experts then briefly reviewed by the FDA.

How does this apply to gases used in MAP?

The most important point to be remembered is that there is no federal certification given to industrial gases employed for food processing be it freezing, formulation or packaging. The gases that are considered 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. … proper manufacturing practices…) are goverened by the food processor or the gas supplier’s customer.

Additionally, hydrogen, carbon monoxide and argon were identified 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 insinuates that the FDA had no questions as to the accuracy of the outside expert’s consensus.

The crucial point to take away is that the any gases with the label “Food Grade” have been certified in house by the manufacturer instead of by the FDA. The certification is by purity determined 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 have learned to keep an eye out for food grade products and like to see clean packages with clear labels. So having predetermined “food grade” cylinders and/or tanks is necessary to succeed in this market as is evidenced by the successful companies naming and trademarking their respective lines of food grade gases.

Additional information on food grade gases and MAP applications are available through PurityPlus. If you’re interested in purchasing food grade gases or other specialty gases for various industries in Albany, contact Noble Gas Solutions at (518) 465-5229 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 be the leader of the marketing efforts of technology worldwide for industrial gas suppliers. He presently consults to the industry on the business specializing in operations, applications and marketing.