GRAS Classification of Gases for the Food Industry

The United States Food and Drug Administration (FDA) classifies about 80% of the US food supply. The FDA is also responsible for reviewing the food product’s packaging along with its ingredients. There are 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 added ingredients are classified Generally Recognized As Safe (GRAS). Industrial gases that are employed in the food industry for Modified Atmosphere Packaging (MAP) and refrigeration are classified as such.

History

In 1958 Congress enacted the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. One item included in the amendment was the definition of food additive:

“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 employed to artificially sweeten soft drinks and grouped as GRAS, were brought into question. The outcome incited 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 carry out all the demands that they were receiving for substances to be classified.

Since then, the materials that were originally 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 concluded by individual experts outside the government. In simpler terms, a GRAS classification before 1997 was sanctioned by the FDA and later than 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 granted to industrial gases utilized 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 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 declared above, gas suppliers are only responsible for the purity of the gas product and the other sanctions (i.e. … proper manufacturing practices…) are regulated by the food processor or the gas supplier’s customer.

Likewise, hydrogen, carbon monoxide and argon were identified 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 classification.

The important fact to take from this article is that the any gases labeled “Food Grade” have been certified in house by the manufacturer instead of by the FDA. The certification is by purity determined 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 prefer 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 evidenced by the major 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 would like to purchase food grade gases or other specialty gases for various industries in Mexico, contact Criogas at 01-800-400-CRIO or contact us via email at informes@criogas.com.

Written by John Segura.

John Segura is a licensed Professional Engineer and a experienced 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 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 now consults to the industry on the business specializing in operations, applications and marketing.