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 administration is also responsible for inspecting not only the ingredients of the food product but the packaging as well. There exist 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 employed in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration are classified into this category.

History

In 1958 Congress enacted 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 employed as an artificial sweetener in soft drinks and grouped as GRAS, began to be questioned. The outcome incited then President Nixon to instruct the FDA to reexamine all substances classified as GRAS. In 1997, the FDA declared that they did not have enough resources to carry out all the insistence that they were receiving for substances to be classified.

Since then, the materials that were originally considered GRAS were upholding 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 specialists 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 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 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 declared above, gas suppliers are only in charge of the purity of the gas and the other sanctions (i.e. … proper manufacturing practices…) are regulated 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. Since then, they been given a GRAS Notice under the heading of “No Questions” which insinuates that the FDA had no questions as to the correctness of the outside expert’s classification.

The crucial point to take from this article is that the any gases labeled “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 are trained 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 crucial to sustain this market as is evidenced by the major companies naming and trademarking their respective lines of food grade gases.

More 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 Sioux Falls, contact A-OX Welding Supply at 605-336-1125 or contact us via email at info@aoxwelding.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 been in charge of 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 now consults to the industry on the business specializing in operations, applications and marketing.