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Gluten Free Certification – What Does It Mean to You?

Currently we have a proposed government definition of the term “gluten-free” for food labeling purposes but no final rule. Under the proposed rule, a labeled gluten-free food has to contain less than 20 parts per million of gluten. When the final rule is released this number could stay the same, go up, or go down—a little or a lot.

The amount of gluten a labeled gluten-free food is allowed to contain is only part of the story. Another part is testing. The FDA stated in its proposed rule that it is tentatively considering using the standard sandwich R5 ELISA and the Morinaga wheat protein ELISA to test food products for gluten when necessary to assess misbranding. In contrast, FDA did not include the omega-gliadin (Skerritt) ELISA among the methods it was considering. One of the limitations discussed in the scientific literature regarding this ELISA is its underestimation of barley protein.

At the present time the R5 ELISA (Ridascreen Gliadin R7001) is widely regarded as the best available validated ELISA for assessing final food product for gluten. In my opinion, all labeled gluten-free foods should be periodically tested using this assay with frequency dependent upon several factors, including raw ingredients used and type of manufacturing facility—gluten free versus shared.

Now and in the future, manufacturers may use whatever test they want to assess their products for gluten. When the gluten-free rule is finalized, testing protocols and testing methods for manufacturers will not be mandated by the FDA. BUT if there is a consumer complaint and the FDA decides to assess a product for gluten, they will use the best available testing method. Similar to the proposed rule, FDA in their preamble to the final rule will likely advise manufacturers about the test(s) they are considering using in their enforcement program. These testing methods may change over time as methods improve. FDA test results will override manufacturer results UNLESS the manufacturer is able to demonstrate that the test they are using is comparable or superior to the test being used by the FDA.

While we wait for the FDA’s rule to be released, there are programs available to help consumers make choices about the gluten-free food they eat. These programs include the Celiac Sprue Association’s Recognition Seal and the Gluten Intolerance Group’s Gluten-Free Certification Mark. But what does it mean if you see a Recognition Seal or Certification Mark on product packaging? What is the allowable level of gluten in these products? What testing methodologies are used? And how frequently are products tested?

Mary Schluckebier, Executive Director of CSA and Cynthia Kupper, Executive Director of GIG both agreed to answer questions for GlutenFreeDietitian.Com.

Very important note: There are plenty of gluten-free manufacturers who do not utilize either CSA’s or GIG’s program but nonetheless are following meticulous safety standards, including testing of products for gluten contamination.

CSA’s Recognition Seal

Answers provided by Mary Schluckebier, Executive Director of CSA. Please note: answers are provided “as is” and have not been edited.

According to CSA’s website, all products accepted for the Recognition Seal Program must test below 5 parts per million of gluten using the sandwich R5 ELISA. Is the test used the standard (validated) R7001 version or the fast R7002 version?

Testing is one part of the CSA Recognition Seal Program to verify the ingredient supplies and final product. Additional testing is generally included in the companies Hazard Analysis Critical Control Points (HACCP) plan. The company HACCP practices and procedures followed by the employees are established to consistently produce the most risk free products for those on a gluten-free regimen. So independent testing is used in the development and end product stages of screening program participants. The ingredient specifications, already limited to risk free choices, and HACCP plan are the central parts of the program for consumer assurance. Products and/or ingredients are sent from the company or purchased in stores periodically. CSA employees transport the samples to the FAARP Lab in Lincoln, Nebraska for independent testing. The cross reactive validated R7001 test for gluten is used according to the manufacturer’s directions. The results must be below the level of quantitation (BLQ) to be considered for the CSA Recognition Seal Program. From time to time other accredited labs and assays are utilized for testing.

Author note: The limit of quantification for the R7001 test is 5 parts per million of gluten (2.5 parts per million of gliadin).

Once a product is accepted into the program is it required to undergo further testing? If so, is a specific test required (e.g., R7001, R7002) and how frequently must the product undergo testing?

Periodic testing of off the shelf company products is scheduled at least yearly, additional testing is based upon risk. Testing is also used when ingredient supplier’s assurances are lacking when there is a change in ingredient suppliers or specifications.

Are manufacturers allowed to test in-house or are they required to submit samples to a third-party lab such as FARRP?

Participants generally include a specific testing schedule and plan in their HACCP plan for purity assurance. 

If manufacturers are allowed to do some testing in house, what tests are they advised to use? Are they ever allowed to use a test that utilizes the omega-gliadin (Skerritt) antibody or are they always advised to use a test that utilizes the R5 antibody? Are they taught how to validate whatever test they are using?

In general the HACCP plan includes employee training and testing procedures. As new tests become available, companies often run parallel testing to help decide the test that best fits their needs.  

The current gluten batch tests have limitations because of the small sample size and the limited protein fractions detectable. The basis of the CSA Recognition Program is limiting ingredients to risk free gluten-free choices, (free of wheat, barley, rye, oats, their crosses and derivatives) and a strong workable HACCP plan. The emphasis on these two aspects, testing is used to verify the process works! This recognizes the extra efforts of companies providing the most risk free of the gluten-free choices.

Thank you, Mary.

GIG’s Certified Gluten-Free Mark

Statement provided by Cynthia Kupper, Executive Director of the Gluten Intolerance Group. Please note: statement is provided “as is” and has not been edited.


According to GFCO’s website, the GFCO mark “assures that the product contains less than 10-ppm gluten.” What test is used to assure this level? Is it the standard validated R5 ELISA (Ridascreen 7001)?

According to GFCO’s website, both the R5 ELISA and the omega-gliadin ELISA (i.e. Skerritt) are used to assess food for gluten. In what situations does GFCO feel it is appropriate to use the omega-gliadin ELISA?

Once a product is accepted into the program is it required to undergo further testing? If so, is a specific test required (e.g., R7001, R7002) and how frequently must the product undergo testing?

Are manufacturers allowed to test in-house or are they required to submit samples to a third-party lab such as FARRP or Bia Diagnostics?

If manufacturers are allowed to do some testing in house, what tests are they advised to use? Are they ever allowed to use a test that utilizes the omega-gliadin antibody or are they always advised to use a test that utilizes the R5 antibody? Are they taught how to validate whatever test they are using?


GFCO uses both R5 Elisa and Skerritt Elisa testing methods in assessing safety of foods for gluten. At times, the combination can provide valuable information. To determine on-going testing frequency required by the company, GFCO uses a combination of risk assessment of raw materials, processing and audit reports. Testing may be required for raw materials and equipment, as well as finished products.

In the absence of a finalized FDA ruling on accepted methodology, GFCO feels it is important to utilize both R5 and Skerritt Elisa methods. Based on the risk assessment, the product, and the company’s current testing abilities, they may test for gluten in-house or send samples to labs.

Companies are required to test on a regular basis. Companies are given a testing packet that includes labs that will consult with companies regarding testing, matrix validation and other issues. GFCO also pulls samples during audits and from point-of-sale to send to outside labs for testing using R5 and periodically Skerritt. In some situations, GFCO will also ask labs to do additional testing such as spiked samples and specialized testing that will help determine specific contaminants.

GFCO collects testing results from companies on a regular basis at random times. This helps assure that companies are following their contractual testing requirements.

All testing that falls outside of GFCO standards are immediately investigated with follow-up testing of the original sample, additional samples from the same lot and other lots. This may include raw materials and auditor-supervised equipment testing. These samples are then sent to a second lab as well. Investigation can also include unannounced audits, increased audits and increased testing requirements. Corrective actions plans can include placing holds or recalls on products or public announcements.

To date, GFCO has required products to be held for further testing, recalled shipments prior to reaching  the distribution system, and required companies to change raw materials in order to correct contamination problems and allow a product to be certified in GFCO’s program.

Thank you, Cynthia.

“Gluten-free,” “certified gluten-free,” “recognition seal,” etc—all of these labeling designations serve as a starting point for conversations with manufacturers. Call them up. Email them. Ask them what they are doing to ensure their food products are gluten free. But please remember, we are all in this together and manufacturers are learning right along with the rest of us.

This article is part two of a series I will be writing on issues related to gluten-free labeling.  Read part one, Survey results: What would you like “gluten-free” to mean? at  http://www.glutenfreedietitian.com/newsletter/2011/02/09/survey-results-what-would-you-like-gluten-free-to-mean/

The next article in the series will take a very close look at the ELISA tests currently used to assess food products for gluten, including the R5 ELISA, omega-gliadin (Skerritt) ELISA, and the Morinaga wheat protein ELISA.

Author Information: Tricia Thompson, MS, RD
© February 2011 by Tricia Thompson

This article was originally published at http://www.glutenfreedietitian.com/newsletter/ and is reprinted at glutenfreeworks.com with permission

Tricia Thompson, MS, RD is an internationally recognized expert in celiac disease and the gluten-free diet. A researcher, consultant, and writer, she is the author of The Gluten-Free Nutrition Guide, The Complete Idiot’s Guide to Gluten-Free Eating, and The American Dietetic Association’s Easy Gluten-Free: Expert Nutrition Advice with More Than 100 Recipes. For more information on celiac disease and the gluten-free diet, visit Tricia’s website at www.glutenfreedietitian.com.

About Tricia Thompson


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