GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) classifies about 80% of the US food supply. The administration also has the responsibility of reviewing 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 exist because they affect components of the product 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 are classified as such.

History

In 1958 Congress implemented the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. One of the items that the amendment covered was the definition of a Food Additive which was:

“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 which are not considered additives and are considered 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 urged then President Nixon to call on the FDA to reexamine all substances classified as 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, previous substances that were considered GRAS were maintaining 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 decided by individual authorities outside the government. Simply put, a GRAS classification before 1997 was sanctioned by the FDA and later than 1997 by consensus 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 used 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 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 gas product and the other sanctions (i.e. … adequate 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 means that the FDA had no questions as to the accuracy of the outside expert’s consensus.

The crucial point to take from this article is that the any gases labeled “Food Grade” have been certified in house by the manufacturer and not 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 learned to search for food grade products and wish to see clean packages with clear labels. So having separate “food grade” cylinders and/or tanks is important to service this market as is evidenced by the major companies naming and trademarking their respective lines of food grade gases.

Further information on food grade gases and MAP applications can be obtained through PurityPlus. If you would like to purchase food grade gases or other specialty gases for various industries in Auburn, contact Spec Air Specialty Gases at or contact us via email at orders@specair.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 led teams of engineers and technicians as an R & D manager for major gas companies. His work guided him to be in charge 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.