GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) regulates about 80% of the US food supply. The Food and Drug Administration is also responsible for analyzing the food product’s packaging along with its ingredients. There are 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 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 into this category.

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.”

Not included are like gas mixtures that are considered additives rather than GRAS.

In the late 60’s cyclamate salts, which were utilized as an artificial sweetener for sodas and grouped as GRAS, began to be reconsidered. The results prompted then President Nixon to call on 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 demands that they were receiving for substances to be classified.

Since then, previous substances that were considered GRAS were keeping 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 determined by individual experts outside the government. In simpler terms, a GRAS classification before 1997 was sanctioned by the FDA and later than 1997 by accord of recognized experts then quickly 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 mentioned, gas suppliers are only responsible for the purity of the 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 recognized 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 correctness of the outside expert’s consensus.

The important fact to take away 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 are trained to look for food grade products and prefer to see clean packages with clear labels. So having separate “food grade” cylinders and/or tanks is crucial to sustain this market as is proven by the dominant companies naming and trademarking their respective lines of food grade gases.

Further 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 Northern Illinois, contact Weldstar at 855-998-4875 or contact us via email at starrant@weldstar.com.

Written by John Segura.

John Segura is a licensed Professional Engineer and a well-rounded executive in the industrial gas industry. He has spent over 30 years gaining experience in marketing, sales, and operations for both domestic and international affairs. He has led 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 presently consults to the industry on the business specializing in operations, applications and marketing.