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 administration is also responsible for reviewing not only the ingredients of the food product but the packaging as well. There are 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 additives 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 substances 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 in soft drinks and considered GRAS, were brought into question. The results prompted then President Nixon to order the FDA to reexamine all substances classified as GRAS. In 1997, the FDA declared that they did not have enough resources to address all the requests 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 after 1997 requesting classification are granted a GRAS Notice which is determined by individual experts outside the government. Simply put, a GRAS classification before 1997 was sanctioned by the FDA and after 1997 by consensus of recognized experts then briefly 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 used for food processing be it freezing, formulation or packaging. The gases that are classified as 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 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.

Additionally, 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 means that the FDA had no questions as to the validity 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 defined by best practice in the manufacture and handling of the product to its final package (cylinders, micro-bulk vessels, transports and large cryogenic vessels). Food processors have been conditioned to look for food grade products and like to see clean packages with clear labels. So having dedicated “food grade” cylinders and/or tanks is important to service 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 are available through PurityPlus. Whether you’re looking for specialty gases to be used in food and beverage applications, or any other industry that utilizes specialty gases, PurityPlus has a plethora of specialty gas products to meet your need. We have a large selection of specialty gases and specialty gas equipment, along with the resources and experts on hand to answer your questions and assist your needs. For more information, browse our online catalog or contact us via our website or at 877-81P-PLUS (877-817-7587).


Written by John Segura.

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