GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) controls about 80% of the US food supply. The Food and Drug Administration is likewise in charge of reviewing not only the ingredients of the food product but the packaging as well. Several 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 added 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.”

This did not include substances like gas mixtures that are classified as additives and not considered GRAS.

In the late 60’s cyclamate salts, which were utilized as an artificial sweetener for sodas and classified as GRAS, began to be reconsidered. The conclusion incited then President Nixon to instruct the FDA to reexamine all substances classified as GRAS. In 1997, the FDA argued that they did not have proper resources to carry out all the insistence 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 requesting classification after 1997 were given a GRAS Notice which is determined by individual authorities outside the government. In simpler terms, a GRAS classification earlier than 1997 was sanctioned by the FDA and later than 1997 by accord of recognized experts then quickly audited by the FDA.

How does this apply to gases used in MAP?

The main objective to keep in mind is that there is no federal certification given to industrial gases utilized 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 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 stated, gas suppliers are only in charge of the purity of the gas product and the other sanctions (i.e. … good manufacturing practices…) are regulated 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 means that the FDA had no questions as to the validity of the outside expert’s classification.

The main objective to learn from this is that the any gases with the label “Food Grade” have been certified in house by the manufacturer instead of 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 been conditioned to search for food grade products and want to see clean packages with clear labels. So having dedicated “food grade” cylinders and/or tanks is important to service this market as is proven by the major companies naming and trademarking their respective lines of food grade gases.

Additional information on food grade gases and MAP applications can be found through PurityPlus. If you are in search of food grade gases or other specialty gases for various industries in El Paso, contact SYOXSA, Inc. at 915-771-7674 or contact us via email at Esteban.Trejo@syoxsa.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 led teams of engineers and technicians as an R & D manager for major gas companies. His work directed 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.