Food Gases

In recent years, the FDA’s understanding and our understanding of food gases have evolved. This article surveys the major food gas issues for today and recommends practical ways to stay ahead of the changing enforcement activities in the future.

What Are Food Gases?

Gases that come into contact with food and beverages are “food gases.” This includes carbon dioxide (and mixtures) used for beverage carbonation, nitrogen used for food packaging, hydrogen used for hydrogenation of food oils, nitrous oxide used for whipped cream, sulfur dioxide used in wine or to prevent oxidation, carbon monoxide used to enhance meat coloration, etc.

Registration

Beginning in 2002, the FDA required food production and warehousing facilities to be registered (one-time). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002.) The understanding and enforcement of this law was inconsistent at first. In 2011, the Food Safety Modernization Act (FSMA) was signed into law. This law requires re-registration of food facilities between October 1 and December 31 of even numbered years beginning in 2012. If your facilities produce, fill or warehouse food gases, they must be registered. Fortunately, the food registration process is generally simpler than the drug registration process. Contact Juliet@asteriskllc.com for a free registration whitepaper and video instructions if you need more information.

Raw Material Qualification

The bulk carbon dioxide, nitrogen, etc. used for food gases must be qualified as food grade. There are several “food grade” specifications, but the final word on food gas specifications is the Food Chemical Codex (FCC). The Compressed Gas Association commodity specification publications are a good summary of the appropriate food specifications. (e.g. CGA G 6.2:2011 Commodity Specification For Carbon Dioxide).  Unlike drug gases, food gases are not necessarily tested when delivered to your bulk tank. Your supplier may submit to you a “certificate of guaranty” to qualify the bulk raw material. We recommend that you obtain the certificate on an annual basis. Alternately, you could receive a “certificate of conformance,” a “certificate of analysis,” or you could qualify the raw material yourself by analyzing the bulk product to FCC specifications.

Lot Numbers Traceability

You should have a record of the lot number for the bulk food products you receive. In addition, the cylinders and containers you fill should receive a lot number. You choose the format of the food grade lot number. You could choose to use the same format as your medical gases. Or you could choose an alternate lot number format (daily, each bulk delivery, etc.). This cylinder lot number is documented on a fill log along with the traceability to the bulk lot number.

The food gas cylinders and containers you deliver must be tracked by lot number as well. You could track these food gas lot numbers in the same manner that you track medical gas lot numbers. Or, you could choose to track the food gas lot numbers in another manner (Excel, etc.)

Cleanliness

The regulations require clean facilities and equipment. If an inspector observes evidence of insect, bird or rodent infestation (droppings), you will likely receive a violation. In addition, you should have a written record that your facility was cleaned and inspected by your personnel.

Looking Ahead

The items above are the major food compliance issues right now. As new regulations are written for the FSMA, we know there will be changes in the future. For example, we will develop industry standard Hazard Analysis and Critical Control Points guidance for your use as the agency clarifies their position.

GAWDA distributors can stay informed about the latest agency actions in a free webinar (GAWDA Food Gas Roundtable) generally held at 2:00 p.m. ET on the first Friday of each month. Contact Juliet@asteriskllc.com if you are not receiving invitations to these free webinars.

Free sample procedures (including the above items) have been developed for GAWDA distributors. Contact Juliet if you would like the sample procedures.

Gases and Welding Distributors Association
Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and tom@asteriskllc.com.