January 2018

In this issue
  • The GFCO Threshold for Whole Commodities
  • Join GFCO at Expo West
  • Gluten-Free Drug Labeling
  • International Use of the GFCO Logo
  • Repackaging and Certification
  • Certification Updates
  • GFCO Contact Information

The GFCO Threshold for
Whole Commodities  
Gluten-free grains, seeds, beans, pulses and legumes are the largest source of unintentional gluten contamination in the food supply. These commodities are often grown, harvested, stored, transported or processed in the same facilities and with the same equipment as wheat, rye and barley. In their whole form, before milling, rolling or other processing, these materials are difficult to sample and test for gluten using typical antibody-based test methods, like ELISA or rapid kits.
This month, GFCO published a manuscript in a special edition of the Journal of AOAC International that defines how the GFCO 10 ppm threshold can be applied to whole grains, beans, seeds, pulses and legumes using visual examination (seed counts). This publication describes a sampling plan and threshold for the number of gluten-containing grains (GCG) allowed per kilogram of a whole commodity to meet the GFCO requirements. A copy of this publication is being distributed with this edition of the newsletter, and is available from GFCO at any time.
Beginning January 1, 2019, GFCO will require all certified whole grains, seeds, beans, pulses and legumes to meet the GFCO threshold of 0.25 GCG/kg, as determined by visual examination . This requirement will apply to primary processors, packaging operations, or any other facility that is selling GFCO-certified whole commodities. Companies may use the sampling plan provided in the GFCO publication, or another validated sampling plan of their own design, as long as they can provide evidence that their sampling plan keeps the probability of the product containing 1 GCG/kg at less than 1%. Companies may begin using this visual examination threshold at any time prior to January 1, 2019, and will be expected to continue to meet the 10 ppm threshold for all antibody-based testing.
An essential component of a visual examination program is the appropriate training of staff. Staff who perform visual examination will fall under the same requirements for training and competency evaluation as those who perform other types of gluten testing. Seed counting services are also available at a number of university, agricultural extension and private laboratories. GFCO recommends the use of ISTA accredited laboratories if a company chooses to outsource their seed counts.


REMINDER: Testing Submissions for the fourth quarter of 2017 were due on January 10th. Please make sure you have submitted your data to .

Join GFCO at Expo West!
The Natural Products Expo West 2018 show in Anaheim is just under two months away and will be here before we know it. With this huge event just around the corner, we have an opportunity for you to share space at our Gluten-Free Certification Organization (GFCO) booth and promote your products to the over 80,000 attendees at Expo West. Our 40x10 booth will again be in the main exhibit hall from March 9th to March 11th and your participation will allow you to interact personally with numerous buyers and distributors, as well as with industry reporters and bloggers who frequently stop by to ask about the companies and products that we are highlighting in our booth space. Our booth provides a great opportunity for companies that would otherwise not be able to showcase their products at an event like Expo West and gain this important exposure at a fraction of traditional event costs.

By participating in this opportunity, you will receive:
  • Shared display space at GIG's Natural Products Expo West booth in 2018. Display space is 36" wide and 12" deep. You may display product packaging, specials, company info or finished goods, or any combination of the aforementioned items (no sampling).
  • Company / Brand Logo on the back display wall of our 40' x 10' booth on the main floor at Expo West.
  • Sales sheet in GFCO's Certified Companies catalog (full page, full color)
  • Highlighting your company on our social media platforms on Facebook, Twitter, Instagram, and the GIG web site,  
  • Ability to provide incentive content (digital coupons and/or discount codes) to all of our GIG members (20,000+) through GIG’s Celebrate Gluten-Free digital publication.
  • Company name and logo featured as an Expo Level member on all partner listings.
Due to the limited space, this is a first come, first served opportunity. Cost to participate and receive all of the above incentives is $2,500. If you are interested in being a part of this largest event for our industry, please contact Channon Quinn at for information on how to register.

FDA Drug Labeling Recommendations
On December 12, 2017 the US Food and Drug Administration (FDA) issued a draft industry guidance document for gluten-free labeling of pharmaceutical drugs, which can be accessed by clicking here . The draft was released to solicit comments, which must be submitted by February 12, 2018. Comments on the draft can be submitted by going to and typing “gluten in drug products” in the search window, or by searching Federal Docket number FDA-2017-D-6352.

The guidance document applies specifically to oral medications, topical drug products applied to or near the lips, and drug products applied inside the mouth, which are collectively referred to as oral drug products. It does not apply to dietary supplements, which are regulated as food, or to products regulated solely as cosmetics.

Rather than the 20 ppm threshold that applies to food products, this guidance document recommends that “any oral drug product that contains wheat gluten as an intentionally added ingredient should be labeled to indicate its presence.” The same recommendation is made for products that intentionally contain wheat flour. The guidance states that other gluten sources, including intentionally added rye or barley, or unintentional contamination with wheat, rye or barley, are so rare, or would occur at such a low level as to not require specific labeling.

Instead of “gluten free” labeling, drug manufacturers are asked to use the phrase “Contains no ingredient made from a gluten-containing grain (wheat, barley or rye)”.

Using the GFCO Logo Internationally
GFCO permits the GFCO certification mark (GFCO Logo) to be used on certified products sold in countries outside of the United States, as long as those products also meet the requirements and thresholds for gluten-free foods in the country of sale. This means that the certified product must meet the requirements of the GFCO certification standard as well as any local/state/national requirements for the labeling of gluten-free foods. It also means that the product must meet any gluten level threshold required by the country of sale if that threshold is below the GFCO threshold of 10 parts per million (ppm). In all cases the stricter requirement, whether held by GFCO or the country of sale, must be met. It is the responsibility of the manufacturer to determine the local, state and national regulations for the packaging, labeling and sale of gluten-free foods for each country in which they will sell GFCO certified product. A list of gluten-free requirements in several countries as of December 2017 is provided below, but the manufacturer must confirm these requirements before selling GFCO labeled product outside of the United States. For information about gluten-free requirements in other countries, contact your exporter, broker, or the importing country.
  • Australia/New Zealand—FSANZ Standard 2.9.5, Food for Special Medical Uses. Threshold is “no gluten” from wheat, rye, barley, oats and related/hybrid grains.
  • European Union and United Kingdom—Commission Implementing Regulation (EU) No. 828/2014. Threshold is 20 ppm gluten from wheat, rye, barley, oats and related/hybrid grains, though individual countries can exempt oats as a gluten source.
  • Canada—Canadian Food and Drug Regulation Section B.24.018. Threshold is “any gluten protein” from wheat, rye, barley, oats and related/hybrid grains, enforced at 20 ppm. Specially produced or processed oats can be sold as gluten free or used in gluten free products, but must be identified as “gluten free oats”
  • Argentina—Argentinean Food Code Chapter XVII Article 1383. Threshold is 10 ppm gluten from wheat, rye, barley, oats and related/hybrid grains
  • Chile—Food Law, Sanitary Regulations for Food Products in Chile, Title XXVIII. Threshold is no gluten from wheat, rye, barley, oats or related grains/hybrids, enforced as non-detectable by laboratory analysis.

Repackaging and GFCO Certification

There are some specific rules around what GFCO refers to as “repackaging”. By GFCO definition, a repackaging operation is one that purchases bulk or pre-packaged goods and simply packages them for sale with the GFCO logo.
In a repackaging facility, GFCO is only able to audit the operations that happen during the packaging stage. For this reason, GFCO can only certify low-risk ingredients in a repackaging operation. These are things like nuts, dried fruit, or chemicals such as baking soda or xanthan gum, or ingredients that are already certified gluten free by GFCO. GFCO cannot certify any products that were manufactured elsewhere at a repackaging operation, unless those manufactured products are made in a GFCO approved facility, and the products are certified gluten free by GFCO.
When GFCO receives a Product & Ingredient list from a new applicant, or as an update from a company that already holds a product certification, GFCO staff will review the list for any instances of repackaging. If there are any questions, GFCO may contact the company to determine if a repackaging situation exists, and if the materials are suitable for repackaging. If any high-risk materials are being repackaged, GFCO will provide the company with options for reducing the risk level of those materials.
If your company wants to certify repackaged products, please let your GFCO customer service representative know so they can provide you with the right information and document requirements to get the repackaged items approved.
Certification Update
The final report for the 2017 GFCO Proficiency Testing round is being sent to all participants in January 2018. Thank you to all of our clients who registered and submitted their results. Keep an eye out for the next PT offering from GFCO, which will happen in late 2019. Registration dates will be announced in future editions of Food Safety First.

All clients carrying a certification contract will be receiving a notice, directly from GFCO, before annual plant audits coming up in the second quarter of 2018 and later. Be sure to look out for those notices and respond if you need to change anything regarding your account.

Keep in mind that GFCO groups annual audits geographically, in order to minimize travel costs for our clients. If you need to postpone an audit, this may increase the travel costs for that audit, because we may not be able to group it with other audits in the same area.
Send Us Your Requests and Ideas
Is there a certification topic that you would like to have more information on, or anything else about the gluten-free industry or manufacturing that you would like to learn more about? Let GFCO know, and we may base future Food Safety First articles on your areas of interest. Email your ideas to, or go to

Customer Service
For general certification
questions and changes to your certification, including changes to Products, Ingredients and manufacturing facilties.
For questions about payments for certification or audits.
Quality Control
For questions about audit
report findings and contract testing requirements.
Ronni Alicea


Regulatory & Standards
For questions about the GFCO Standard requirements, testing methods, and to report positive gluten test results > 10 ppm in finished product.
Laura Allred
Vice President
Channon Quinn
Gluten Intolerance Group
31214 124th Ave SE Auburn, WA 98092
P: (253) 833-6655
F: (253) 833-6675 
Gluten Intolerance Group of North America® is a 501c3 nonprofit Washington State corporation. 
Tax ID 91-1458226.