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 likewise in charge of analyzing not only the ingredients of the food product but the packaging as well. There exist ingredients that do not alter the food product’s taste or makeup and are present for reasons such as 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 fall under this classification.

History

In 1958 Congress created the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. One item included in the amendment was the definition of food additive:

“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 considered additives rather than GRAS.

In the late 60’s cyclamate salts, which were used as an artificial sweetener in soft drinks and considered GRAS, began to be reconsidered. The results urged then President Nixon to call on the FDA to reexamine all substances classified as GRAS. 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, substances that were previously classified as 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 concluded by individual experts outside the government. To explain simply, a GRAS classification prior to 1997 was sanctioned by the FDA and later than 1997 by accord of recognized experts then concisely reviewed by the FDA.

How does this apply to gases used in MAP?

The most important point to be remembered 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 in charge of the purity of the gas and the other sanctions (i.e. … good manufacturing practices…) are controlled by the food processor or the gas supplier’s customer.

Additionally, 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 insinuates that the FDA had no questions as to the accuracy of the outside expert’s consensus.

The crucial point to learn from this is that the any gases considered “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 look for food grade products and prefer to see clean packages with clear labels. So having dedicated “food grade” cylinders and/or tanks is important to service this market as is evidenced 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’re interested in purchasing food grade gases or other specialty gases for various industries in Minneapolis, contact Toll Company at 612-581-9889 or contact us via email at thea@tollgas.com.

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 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.