GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) classifies approximately 80% of the US food supply. The administration also has the responsibility of analyzing the packaging of the food as long as the ingredient of the food product as well. There exist ingredients that do not alter the food product’s taste or makeup and are added because they affect factors like 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.

History

In 1958 Congress created the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. The amendment defined food additive as:

“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 in soft drinks and considered GRAS, began to be reconsidered. 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 upholding their classification and can be found in the Code of Federal Regulations (21 CFR). All substances that requested classification after 1997 were given a GRAS Notice which is decided by individual experts outside the government. To explain simply, a GRAS classification before 1997 was sanctioned by the FDA and following 1997 by agreement of recognized experts then concisely approved 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 assigned 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 details 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 in charge of the purity of the gas and the other sanctions (i.e. … adequate manufacturing practices…) are regulated by the food processor or the gas supplier’s customer.

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

The crucial point to learn from this 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 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 prefer to see clean packages with clear labels. So having separate “food grade” cylinders and/or tanks is important to service this market as is evidenced by the dominant companies naming and trademarking their respective lines of food grade gases.

Additional information on food grade gases and MAP applications can be obtained through PurityPlus. If you would like to purchase food grade gases or other specialty gases for various industries in Riverside, contact Elite Air at (951) 686-7822 or contact us via email at info@cal-tool.com.

Written by John Segura.

John Segura is a licensed Professional Engineer and a experienced executive in the industrial gas industry. He has spent over 30 years gaining experience in marketing, sales, and operations for both domestic and international affairs. 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.