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 Food and Drug Administration also has the responsibility of reviewing not only the ingredients of the food product but the packaging as well. Several ingredients that do not change the food product’s taste or makeup and are added because they affect factors like 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 into this category.

History

In 1958 Congress implemented 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.”

This did not include substances like gas mixtures that are classified as additives and not considered GRAS.

In the late 60’s cyclamate salts, which were utilized to artificially sweeten soft drinks and classified as GRAS, began to be reconsidered. The outcome incited then President Nixon to instruct the FDA to reevalute the components that were considered GRAS. In 1997, the FDA claimed that they did not have adequate 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 keeping 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 determined by individual experts outside the government. In simpler terms, a GRAS classification earlier than 1997 was sanctioned by the FDA and following 1997 by consensus of recognized experts then quickly 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 employed 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 describes 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 accountable for the purity of the product and the other sanctions (i.e. … proper manufacturing practices…) are regulated by the food processor or the gas supplier’s customer.

Additionally, 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 means that the FDA had no questions as to the validity of the outside expert’s classification.

The important fact to learn from this is that the any gases considered “Food Grade” have been certified in house by the manufacturer instead of by the FDA. The certification is by purity obtained 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 been conditioned to keep an eye out for food grade products and want to see clean packages with clear labels. So having separate “food grade” cylinders and/or tanks is crucial to sustain this market as is shown by the dominant companies naming and trademarking their respective lines of food grade gases.

Further information on food grade gases and MAP applications are available through PurityPlus. If you would like to purchase food grade gases or other specialty gases for various industries in Mexico, contact AOC Mexico S.A. de C.V. at 818-647-7427 or contact us via email at herrmann@aoc.com.mx.

Written by John Segura.

John Segura is a licensed Professional Engineer and a well-rounded executive in the industrial gas industry. He has over 30 years of experience covering sales, marketing and operations both domestic and international. He has been a leader to teams of engineers and technicians as an R & D manager for major gas companies. His work guided him to be the leader of the marketing efforts of technology worldwide for industrial gas suppliers. He currently consults to the industry on the business specializing in operations, applications and marketing.