GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) controls approximately 80% of the US food supply. The Food and Drug Administration is likewise in charge of reviewing the food product’s packaging along with its ingredients. There are ingredients that do not affect the food product’s taste or makeup and are present for reasons such as shelf preservation, color and aroma. These 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 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 which are not considered additives and are considered GRAS.

In the late 60’s cyclamate salts, which were utilized to artificially sweeten soft drinks and grouped as GRAS, began to be questioned. The conclusion incited then President Nixon to order the FDA to reevalute the components that were considered GRAS. In 1997, the FDA declared that they did not have enough resources to address 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 after 1997 requesting classification are granted a GRAS Notice which is concluded by individual experts outside the government. Simply put, a GRAS classification before 1997 was sanctioned by the FDA and after 1997 by consensus of recognized experts then quickly 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 used 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 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 declared above, gas suppliers are only responsible for the purity of the gas 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 identified 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 validity of the outside expert’s consensus.

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 and not by the FDA. The certification is by purity defined 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 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 are available through PurityPlus. If you’re interested in purchasing food grade gases or other specialty gases for various industries in Portland, contact Cryo-Source at 503-235-0168 or contact us via email at paulb@industrialsource.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 directed him to be the leader of the marketing efforts of technology worldwide for industrial gas suppliers. He presently consults to the industry on the business specializing in operations, applications and marketing.