GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) controls approximately 80% of the US food supply. The administration is also responsible for inspecting not only the ingredients of the food product but the packaging as well. There exist 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 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 as such.

History

In 1958 Congress enacted 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.”

Not included 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 for sodas and classified as GRAS, were brought into question. The outcome urged then President Nixon to call on the FDA to reevalute the components that were considered GRAS. In 1997, the FDA argued that they did not have proper resources to fulfill all the requests that they were receiving for substances to be classified.

Since then, the materials that were originally considered GRAS were maintaining 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 concluded by individual specialists outside the government. To explain simply, a GRAS classification earlier than 1997 was sanctioned by the FDA and later than 1997 by consensus of recognized experts then briefly reviewed 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 employed 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 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 stated, gas suppliers are only in charge of the purity of the product and the other sanctions (i.e. … adequate manufacturing practices…) are controlled 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 main objective 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 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 search for food grade products and like to see clean packages with clear labels. So having separate “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.

More 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 Winona, contact Mississippi Welders Supply Co., Inc. at (507) 454-5231 or contact us via email at winona@mwsco.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 lead 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.