GFCO

Gluten-Free Certification Organization

Gluten-Free You Can Easily See!

Frequently Asked Questions

Gluten in the food industry refers to storage proteins found in all grains. These storage proteins are beneficial in food production.

Gluten-free, to the medical community refers only to the storage proteins known to damage the small intestine for persons with gluten sensitive enteropathy (celiac disease and dermatitis herpetiformis). Gluten-free diets avoid the storage proteins found in wheat, rye, and barley.

Who should eat gluten-free food?

People who have been advised by their physician to be on a gluten-free diet should eat gluten-free food. This would include, but not be limited to, people with celiac disease, or gluten intolerance.

How do I know if I have celiac disease?

Blood tests are available to screen for celiac disease but a positive small bowel biopsy is required to confirm the diagnosis of celiac disease.

How can I learn more about celiac disease?

The Gluten Intolerance Group® can help you learn more about Celiac Disease. The website is www.gluten.net.

Does gluten-free mean individuals with severe wheat allergy can eat the product?

Not necessarily, you should consult your physician. Gluten-free foods are foods safe for persons with celiac disease. They have none or very low levels of the 'gluten' proteins that could be harmful to persons with celiac disease. Celiac disease is a t-cell mediated reaction. Wheat allergies involve an IgE-mediated reaction to the wheat proteins albumin and globulin fractions. In rare situations, gluten could also induce an IgE-mediated reaction.

Certification

How does gluten-free certification benefit consumers?

Gluten-free certification benifits consumers by giving them confidence that a product is gluten-free. This not only reassures the consumer that the product has been tested and the site inspected, but it also saves the consumer time that would have been spent calling the manufacturer for the gluten-free status of the product.

How is gluten-free certification done?

Certification is a yearly process based on ingredient review, on-site inspection and product testing. Some facilities require multiple un-announced inspections throughout the year.

Who performs the inspection?

The GFCO was developed in cooperation with the Food Services, Inc., a subsidiary of the Orthodox Union (the “OU”), the world’s largest and oldest kosher certification agency. The OU’s nearly 500 field representatives, proficient in modern food production techniques and chemical and biological processes, will conduct plant inspections and product reviews for the GFCO.

How often is a product inspected or tested?

The number of times an inspector is in the plant to review processes depends on a number of factors including the products being certified, the type of plant, etc. GF Certification is established for each ingredient in the final product, as well as the processing aids. Products may be randomly tested in the plant or sent out for independent testing as requested by GFCO.

Are Dedicated lines important?

Yes. Even if the line is cleaned, if a gluten-free product is run on the same line after gluten containing products, then cross contamination can occur. Dedicated lines for gluten-free products greatly reduce the chances of cross contamination.

Does gluten-free certification guarantee that a product is gluten-free?

The mark assures that the product contains less than 10-ppm gluten (5-ppm gliadin) and similar proteins from rye and barley as measured by using testing methods that are accepted for gluten testing by analytical associations such as the Association of Analytical Communities (AOAC), testing researchers and other such agencies. No testing method is available that measures to zero.

Is the test that measures the lowest level always the best test?

Not necessarily. The GFCO Scientific Team takes into consideration a number of factors when determining the standard for testing, including feasibility, cost, scientific findings, sensitivity and specificity, as well as production procedures.

How do the FDA's Public Meetings and eventual rulings on Gluten-Free Labeling of Foods affect or differ from the GFCO program?

As a global program, the GFCO uses the highest standards for gluten-free ingredients and a safe processing environment based on a continual review of the current scientific and testing methodologies, existing global standards such as Codex, WHO, and Canada, balanced by reasonable application by the manufacturer.

The FDA is mandated by law to draft and implement a proposed definition for 'gluten-free' and how it will be used on a food labels in the U.S. by 2008. GFCO monitors and participates in the FDA meetings as observers and invited guests when appropriate. This allows us to keep abreast of the FDA's work. GFCO gluten-free standards will meet or exceed the FDA final rulings. More details are available at the FDA Center for Food Safety & Applied Nutrition web site:
http://www.cfsan.fda.gov/~dms/wh-alrgy.html

Manufacturers

How does gluten-free certification benefit manufacturers?

Gluten-free certification benefits the manufacturers because it gives them the credibility, recognition, and support that they have provided a gluten-free product. The inspections given by the GFCO will also verify that the company is providing high standards in producing their product, with minimum cross contamination. The manufacturers will also save time and resources that would have been spent answering questions regarding the gluten-free status of their products.

Is the certification done by facility or by product?

Individual products are certified.

What happens if one of my suppliers changes vendors and my product has already been certified?

This is covered under the contract agreement. GFCO must be notified and the changes in ingredients approved before the product can be continued to be certified.

How long is the gluten-free certification mark valid?

The certification of products is valid for one year, but renews annually. As long as the product meets GFCO certification standards and the company is meeting contractual agreements, the mark remains available to that product.

How much does certification cost a company to join the new GFCO program?

The certification costs are based on a number of factors including inspection time and the amount of testing required to ensure safe products. These costs will vary depending on the risk profile of the manufacturing environment and the complexity (number of ingredients and products) of the plant. Ultimately, the certification cost as a percent of total manufacturing costs should be minimal...a small fraction of total manufacturing costs. The net benefit (increased consumer confidence in their products) to manufacturers should be far greater than the costs.

FDA Ruling and GFCO

What impact will the FDA ruling have on GFCO?

The Scientific Team for GFCO will review the rulings as it affects the GFCO program. The scientific team anticipated this type of ruling in establishing the guidelines for GFCO, with the mission of GFCO to provide the highest quality program that would meet or exceed the FDA requirements.

Will GFCO change its standard for GF certification to match the FDA standard?

No. Our goal is to provide a certification program that has higher standards in order to give consumers greater confidence in the certification process.

Can we use the full GFCO symbol on our packages now?

We will consult with our attorney, but believe that some products may be able to use the full logo. However not all products will be able to use the logo at this time. This would include products with oats and oat-based ingredients. As soon as the attorney has approved release of the full GFCO logo, you will be informed.

How will the FDA recommendation for use of ELISA testing methods affect the testing methods used by GFCO?

GFCO scientific and legal team will review this. At this time, GFCO is using both Skerritt and ELISA testing methods. GFCO is aware of the on-going debate in the scientific community about the sensitivity and specificity of various testing methods. Research to be published shortly suggests that both ELISA and Skerritt may have weaknesses that can be complimented by using both methods. We feel that by using both methods, we are able to more accurately assure GF status.

I do not use both testing methods. Am I in compliance with GFCO standards?

Yes, you probably are. Be sure to review your contract for the accepted testing methods for your products. GFCO will use various testing methods when testing products. We also make requests of the outside labs we use to use various testing methods – which may or may not be the same testing method you use in the facility.

Will the FDA ruling make if more difficult or costly to become certified?

No. The FDA ruling should have no impact on the GFCO certification process. GFCO voluntarily asked the FDA, USDA, and Health Canada to review our program. All have indicated our program works well with the rules in their agencies. We continue to ask various regulatory agencies to look at our program for potential conflicts with the law.

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