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 Food and Drug Administration also has the responsibility of analyzing not only the ingredients of the food product but the packaging as well. There are ingredients that do not affect the food product’s taste or makeup and exist because they affect components of the product such as shelf preservation, color and aroma. These additives 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 as such.

History

In 1958 Congress created 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.”

This did not include substances 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 grouped as GRAS, began to be reconsidered. The conclusion incited then President Nixon to order the FDA to reexamine all substances classified as GRAS. In 1997, the FDA claimed that they did not have adequate resources to address 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 that requested classification after 1997 were given a GRAS Notice which is decided by individual authorities outside the government. Simply put, a GRAS classification prior to 1997 was sanctioned by the FDA and later than 1997 by accord 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 given to industrial gases utilized 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 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 mentioned, gas suppliers are only responsible for the purity of the gas product and the other sanctions (i.e. … good manufacturing practices…) are goverened by the food processor or the gas supplier’s customer.

In addition, hydrogen, carbon monoxide and argon were recognized 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 decision.

The main objective to take away is that the any gases labeled “Food Grade” have been certified in house by the manufacturer rather than 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 are trained to keep an eye out 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 demonstrated by the successful companies naming and trademarking their respective lines of food grade gases.

Additional 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 Atlanta, GA, contact Sidney Lee Medical & Scientific Gases at 770-946-4287 or contact us via email at Grace.hoffman@sidneylee.com.

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 directed him to be in charge of 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.