GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) regulates approximately 80% of the US food supply. The administration is also responsible for analyzing the packaging of the food as long as the ingredient of the food product as well. There exist 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 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 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 considered GRAS, were brought into question. The conclusion urged then President Nixon to order the FDA to reevalute the components that were considered GRAS. In 1997, the FDA argued that they did not have proper 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 keeping 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. To explain simply, 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 most important point to be remembered is that there is no federal certification granted 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 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 stated, gas suppliers are only accountable for the purity of the gas product and the other sanctions (i.e. … adequate manufacturing practices…) are regulated by the food processor or the gas supplier’s customer.

Likewise, hydrogen, carbon monoxide and argon were acknowledged 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 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 labeled “Food Grade” have been certified in house by the manufacturer rather than by the FDA. The certification is by purity determined by proper handling and manufacturing of the final product until it reaches 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 important to service this market as is proven 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 would like to purchase food grade gases or other specialty gases for various industries in Pittsburgh, contact Greco Gas at (724) 226-3800 or contact us via email at info@grecogas.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 a leader to teams of engineers and technicians as an R & D manager for major gas companies. His work guided him to be the leader 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.