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 also responsible for reviewing the packaging of the food as long as the ingredient of the food product as well. There are 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 used in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration are classified into this category.

History

In 1958 Congress created the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. The amendment defined food additive as:

“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 utilized to artificially sweeten soft drinks and considered GRAS, began to be questioned. The conclusion incited then President Nixon to call on the FDA to reevalute the components that were considered GRAS. In 1997, the FDA claimed that they did not have adequate resources to carry out 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 after 1997 requesting classification are granted a GRAS Notice which is determined by individual authorities outside the government. In simpler terms, a GRAS classification before 1997 was sanctioned by the FDA and later than 1997 by accord of recognized experts then briefly 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 employed 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 mentioned, gas suppliers are only accountable for the purity of the product and the other sanctions (i.e. … adequate 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 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 accuracy of the outside expert’s decision.

The main objective to take away is that the any gases with the label “Food Grade” have been certified in house by the manufacturer rather than 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 have learned to search for food grade products and wish to see clean packages with clear labels. So having predetermined “food grade” cylinders and/or tanks is necessary to succeed in this market as is shown by the dominant 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 Columbus, contact Delille Oxygen Company at (614) 444-1177 or contact us via email at scotta@delille.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.