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 the packaging of the food as long as the ingredient of the food product as well. Several ingredients that do not change 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 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.”

Not included are like gas mixtures that are classified as additives and not considered GRAS.

In the late 60’s cyclamate salts, which were used as an artificial sweetener in soft drinks and considered GRAS, began to be reconsidered. The conclusion urged then President Nixon to order the FDA to reconsider all substances that fit the GRAS classification. In 1997, the FDA claimed that they did not have adequate resources to carry out all the insistence that they were receiving for substances to be classified.

Since then, substances that were previously classified as 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 concluded by individual experts outside the government. Simply put, a GRAS classification earlier than 1997 was sanctioned by the FDA and later than 1997 by agreement of recognized experts then concisely 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 given to industrial gases utilized for food processing be it freezing, formulation or packaging. The gases that are given the classification of 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 mentioned, gas suppliers are only accountable for the purity of the gas and the other sanctions (i.e. … adequate manufacturing practices…) are controlled by the food processor or the gas supplier’s customer.

In addition, hydrogen, carbon monoxide and argon were acknowledged 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 classification.

The important fact to take from this article 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 obtained 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 been conditioned to look for food grade products and like to see clean packages with clear labels. So having dedicated “food grade” cylinders and/or tanks is necessary to succeed in this market as is demonstrated by the successful companies naming and trademarking their respective lines of food grade gases.

Additional information on food grade gases and MAP applications can be obtained through PurityPlus. If you’re interested in purchasing food grade gases or other specialty gases for various industries in Springfield, contact ILMO Products Company at (217) 245-2183 or contact us via email at info@ilmoproducts.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 lead 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.