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 administration is likewise in charge 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 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, began to be questioned. The results prompted 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 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 after 1997 requesting classification are granted a GRAS Notice which is concluded by individual experts outside the government. To explain simply, a GRAS classification earlier than 1997 was sanctioned by the FDA and later than 1997 by accord 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 given to industrial gases employed 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 stated, gas suppliers are only accountable for the purity of the gas and the other sanctions (i.e. … adequate manufacturing practices…) are goverened by the food processor or the gas supplier’s customer.

Likewise, 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 indicates that the FDA had no questions as to the validity of the outside expert’s decision.

The main objective to take away is that the any gases with the label “Food Grade” have been certified in house by the manufacturer and not by the FDA. The certification is by purity determined by adequate handling and manufacturing practices until the product reaches its final package (cylinders, micro-bulk vessels, transports and large cryogenic vessels). Food processors have learned to look for food grade products and prefer 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 demonstrated 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 found through PurityPlus. If you would like to purchase food grade gases or other specialty gases for various industries in Denver, contact Rocky Mountain Air Solutions at (303) 777-6671 or contact us via email at pevans@rockymountainair.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 been in charge of 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 now consults to the industry on the business specializing in operations, applications and marketing.