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 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 change the food product’s taste or makeup and exist because they affect components of the product such as 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 into this category.

History

In 1958 Congress implemented 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.”

This did not include substances like gas mixtures which are not considered additives and are considered GRAS.

In the late 60’s cyclamate salts, which were utilized as an artificial sweetener in soft drinks and classified as GRAS, were brought into question. The conclusion incited then President Nixon to order 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, substances that were previously classified as were keeping 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 experts outside the government. In simpler terms, a GRAS classification earlier than 1997 was sanctioned by the FDA and later than 1997 by consensus of recognized experts then quickly audited 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 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 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 responsible for the purity of the product and the other sanctions (i.e. … good manufacturing practices…) are controlled by the food processor or the gas supplier’s customer.

In addition, 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 indicates that the FDA had no questions as to the accuracy of the outside expert’s consensus.

The main objective to take away 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 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 search for food grade products and like to see clean packages with clear labels. So having dedicated “food grade” cylinders and/or tanks is crucial to sustain this market as is demonstrated by the dominant companies naming and trademarking their respective lines of food grade gases.

Further information on food grade gases and MAP applications can be found through PurityPlus. If you’re interested in purchasing food grade gases or other specialty gases for various industries in St. Louis, contact Cee Kay Supply, Inc. at 314.644.3500 or contact us via email at benv@ceekay.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 guided him to be the leader 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.