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 is also responsible for reviewing 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 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 employed in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration are classified as such.

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.”

Excluded 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 in soft drinks and considered GRAS, were brought into question. The conclusion prompted then President Nixon to call on the FDA to reconsider all substances that fit the GRAS classification. In 1997, the FDA argued that they did not have proper resources to fulfill all the insistence 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 after 1997 requesting classification are granted a GRAS Notice which is determined by individual experts outside the government. To explain simply, a GRAS classification before 1997 was sanctioned by the FDA and following 1997 by accord of recognized experts then concisely 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 granted to industrial gases used 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 declared above, gas suppliers are only responsible for the purity of the gas 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 identified as ingredients after 1997 and are not listed in 21 CFR. They have since that time been given a GRAS Notice under the heading of “No Questions” which insinuates that the FDA had no questions as to the correctness of the outside expert’s classification.

The main objective to take from this article 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 defined by best practice in the manufacture and handling of the product to 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 prefer 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 major 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’re interested in purchasing food grade gases or other specialty gases for various industries in Fresno, contact Fresno Oxygen & Welding Supplies/Barnes Welding Supply at 559-341-4456 or contact us via email at info@barnesspecialtygases.com.

Written by John Segura.

John Segura is a licensed Professional Engineer and a experienced 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 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.