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 FDA is also responsible for inspecting the food product’s packaging along with its ingredients. Several ingredients that do not change 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 employed in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration fall under this classification.

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.”

This did not include substances like gas mixtures that are considered additives rather than GRAS.

In the late 60’s cyclamate salts, which were utilized as an artificial sweetener in soft drinks and grouped as GRAS, were brought into question. 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 fulfill 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 after 1997 requesting classification are granted a GRAS Notice which is determined by individual experts outside the government. Simply put, a GRAS classification earlier than 1997 was sanctioned by the FDA and following 1997 by consensus of recognized experts then concisely reviewed 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 employed 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 stated, 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.

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 means that the FDA had no questions as to the correctness of the outside expert’s consensus.

The crucial point to take away is that the any gases considered “Food Grade” have been certified in house by the manufacturer rather than by the FDA. The certification is by purity obtained 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 learned to look for food grade products and like 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 successful 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 are in search of food grade gases or other specialty gases for various industries in Richmond, Virginia, contact Arc3 Gases at (804) 644-4521 or contact us via email at nickk@arc3gases.com.

Written by John Segura.

John Segura is a licensed Professional Engineer and a experienced executive in the industrial gas industry. He has over 30 years of experience covering sales, marketing and operations both domestic and international. He has been in charge of teams of engineers and technicians as an R & D manager for major gas companies. His work eventually led 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.