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 inspecting the packaging of the food as long as the ingredient of the food product 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 added ingredients 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 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 that are classified as additives and not 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 results prompted then President Nixon to instruct the FDA to reevalute the components that were considered GRAS. In 1997, the FDA claimed that they did not have adequate resources to fulfill 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 concluded by individual experts outside the government. In simpler terms, a GRAS classification prior to 1997 was sanctioned by the FDA and following 1997 by agreement of recognized experts then quickly 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 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 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 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.

Likewise, hydrogen, carbon monoxide and argon were recognized 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 means that the FDA had no questions as to the validity of the outside expert’s decision.

The important fact to take away 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 are trained to search for food grade products and like to see clean packages with clear labels. So having predetermined “food grade” cylinders and/or tanks is crucial to sustain 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 are available through PurityPlus. If you would like to purchase food grade gases or other specialty gases for various industries in Cincinnati, contact Wright Brothers at 800-637-2222 or contact us via email at mike@expectthebest.com.

Written by John Segura.

John Segura is a licensed Professional Engineer and a well-rounded 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 led teams of engineers and technicians as an R & D manager for major gas companies. His work guided him to be the leader 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.