GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) classifies approximately 80% of the US food supply. The Food and Drug Administration also has the responsibility of analyzing not only the ingredients of the food product but the packaging as well. There exist ingredients that do not change the food product’s taste or makeup and are present for reasons such as shelf preservation, color and aroma. These additives 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 enacted 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.”

Excluded are like gas mixtures that are considered additives rather than GRAS.

In the late 60’s cyclamate salts, which were employed to artificially sweeten soft drinks and grouped as GRAS, were brought into question. The outcome incited 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 address all the insistence that they were receiving for substances to be classified.

Since then, previous substances that were considered GRAS were upholding their classification and can be found in the Code of Federal Regulations (21 CFR). All substances requesting classification after 1997 were given a GRAS Notice which is decided by individual specialists outside the government. To explain simply, a GRAS classification before 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 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 classified as GRAS are carbon dioxide, helium, nitrogen, nitrous oxide and propane. The Code of Federal Regulations section 184.1 details 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 product and the other sanctions (i.e. … proper manufacturing practices…) are regulated by the food processor or the gas supplier’s customer.

Likewise, hydrogen, carbon monoxide and argon were acknowledged 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 indicates 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 adequate handling and manufacturing practices until the product reaches its final package (cylinders, micro-bulk vessels, transports and large cryogenic vessels). Food processors have been conditioned 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 important to service this market as is shown 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’re interested in purchasing food grade gases or other specialty gases for various industries in Southern California, contact WestAir Specialty Gases and Equipment at 866-WESTAIR or contact us via email at info@westairgases.com.

Written by John Segura.

John Segura is a licensed Professional Engineer and a well-rounded 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 in charge of teams of engineers and technicians as an R & D manager for major gas companies. His work directed 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.