GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) classifies approximately 80% of the US food supply. The FDA is likewise in charge of reviewing the food product’s packaging along with its ingredients. There exist ingredients that do not affect the food product’s taste or makeup and exist because they affect components of the product such as shelf preservation, color and aroma. These added ingredients are classified Generally Recognized As Safe (GRAS). Industrial gases that are used in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration fall under this classification.

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.”

Excluded are like gas mixtures which are not considered additives and are considered GRAS.

In the late 60’s cyclamate salts, which were used as an artificial sweetener for sodas and grouped as GRAS, began to be reconsidered. The results urged then President Nixon to instruct the FDA to reconsider all substances that fit the GRAS classification. In 1997, the FDA argued that they did not have proper resources to carry out all the requests 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 that requested classification after 1997 were given a GRAS Notice which is concluded by individual experts outside the government. In simpler terms, a GRAS classification prior to 1997 was sanctioned by the FDA and after 1997 by agreement of recognized experts then quickly reviewed by the FDA.

How does this apply to gases used in MAP?

The essential point to take away 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 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 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. They have since that time been given a GRAS Notice under the heading of “No Questions” which insinuates that the FDA had no questions as to the validity of the outside expert’s decision.

The crucial point to learn from this 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 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 keep an eye out 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 shown by the successful companies naming and trademarking their respective lines of food grade gases.

More information on food grade gases and MAP applications can be found through PurityPlus. If you’re interested in purchasing food grade gases or other specialty gases for various industries in Western Michigan, contact GTW at 616-754-6120 or contact us via email at darrengtwsupplies@yahoo.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 in charge 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.