What is the mission of the Gluten-Free Certification Organization?

Established in 2005, The Gluten-Free Certification Organization (GFCO) is dedicated to providing affordable certification services to producers of gluten-free products using quality assessment and control measures throughout production, in order to provide assurance to consumers of the safety of their foods.

What is the value added effect of GF labeling?

GFCO certification provides a certification seal that is easily identified and provides consumer assurance that the product meets strict standards for gluten-free.

What percentage of the gluten-free market uses the GFCO certification logo?

In 2013, GFCO certified approximately 26% of the gluten-free product market, based on SPINS data. SPINS conducts independent market trend research of a number of markets, including the gluten-free market using point of sale information collected in natural foods markets. GFCO has partnered with SPINS on the gluten-free market research. GFCO certified products are expanding into mainstream retail markets as well as the natural markets.

How does GFCO differ from other gluten-free certification companies?

• GFCO has no hidden fees and no application fee.
• GFCO requires ongoing Inspector training and demonstration of knowledge proficiency.
• GFCO Inspectors undergo a review process of their auditing skills regularly.
• GFCO provides 1:1 and group education programs and consultations.

CONSUMERS

How does gluten-free certification benefit consumers?

Gluten-free certification benefits 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.

Is certification required to label a product gluten-free?

No. Certification is a voluntary program, often sought by companies who value third-part audits and certifications to set themselves apart from other companies by meeting stricter standards. 

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

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

What happens if I think a product made me sick?

GFCO has a Consumer Complaint process.. Contact GFCO at admin@gluten.org. The process includes:

• A request to have the remaining product sent to GFCO for testing.
• Purchase information, including date, location, and product identification are collected.
• A health professional will consult with the consumer about their experience.
• A review of audits and testing records of the company and an unannounced audit if deemed necessary.
• Independent lab testing of the product from the consumer, point of sale purchases if they can be found matching the product information collected from the consumer, and retained samples from the company.
• Evaluation of incident includes a closing report to the consumer, a Corrective Action Plan (CAP) with the company, if warranted. CAP may include unannounced audits, increased audits, testing and other monitoring.

What happens if a product does not meet GFCO standards?

GFCO has a number of recourse options available to enforce compliance with GFCO standards and contract agreements, including “pull back” or holding of product for additional evaluation, consumer alerts, fines, and decertification.

How are proceeds from the certification used?

The proceeds from certification are used to support the continuing advancements of the program, product testing, quality control research, and the support of GIG’s social and awareness programs.

CERTIFICATION

STANDARDS

What are GFCO’s requirements for Gluten-Free Certification?
Companies wishing to obtain GFCO certification and use the GFCO logo on their products must meet
all of the requirements described in the GFCO Standard, which includes management, organizational
and production requirements as well as verification that finished products contain no more than 10
ppm of gluten. Further:

• GFCO does not allow the use of any ingredient that is derived from wheat, rye, barley or
  hybrids of these grains in products certified gluten-free, unless such ingredient has been
  processed to remove gluten, using testing methods validated for the specific ingredient matrix,
  and the ingredient tests at 10 ppm or less gluten.
•  Wheat Starch: GFCO will allow ingredients that have been processed to remove gluten,such as
  wheat starch to be used in a certified product, IF:
  •  The ingredient tests at 10 ppm or less gluten AND
  •  The finished product tests at 10 ppm or less gluten
• Malt Ingredients: Due to the current lack of scientifically reliable and validated
  testing methods,GFCO does not allow malted, fermented and hydrolyzed ingredients or finished products
  made from wheat, rye, barley or hybrids of these grains to be certified gluten-free. GFCO will
  monitor the ongoing research of a validated method for such ingredients or products and
  consider any new methods for future updates to GFCO standards.
• Oats: Oats may be certified as long as the growing, harvesting, milling and other production of the oats have been validated to prevent cross-contamination and the finished product is 10 ppm or less gluten.
• Grasses (wheat, barley, etc.): Grasses if properly harvested and processed to be 10 ppm or less gluten may be certified gluten-free
•  All ingredients used in GFCO certified products, as well as finished products must test to 10ppm gluten or less.
•  Blending of ingredients containing levels of gluten higher than 10ppm into a finished product to dilute gluten concentrations is not accepted by GFCO.

Can oats be certified?
Yes. Oats certified gluten-free by GFCO must meet the GFCO standard of being 10 ppm gluten or
less.

Can products with wheat starch be certified?
Yes, Wheat starch that has been processed to remove gluten and is less than 10 ppm as an ingredient
may be used in a gluten-free product, as long as the finished product also contains 10 ppm gluten or
less.

Can certified products be sold in other countries?
Yes. GFCO certification is not a replacement for the food safety standards and laws of any country.
Products sold with the GFCO logo, are required to meet all the requirements for gluten-free products
of the country of import or export.

Who performs the audits?
GFCO works with ISO 17020 inspection agencies and independent auditors who have years of
experience performing Hazard Analysis and Critical Control Point (HACCP) Compliance, organic,
Global Food Safety, and kosher audits of companies worldwide. Inspectors may also have experience
in quality control and safety programs in plants.

Can anyone use the GFCO Certified Gluten-Free logo?
No. The logo is a registered trademark owned by the Gluten Intolerance Group of NA. Companies
and individuals using the mark without express permission and without a contract are in violation of
trademark law, and are pursued by GIG’s legal department.

PROCESS

How is gluten-free certification done?
Certification is a yearly process based on ingredient review and on-site inspection. Companies are
also required to communicate regularly their testing results to GFCO.

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

What is the cost for certification?
The certification costs are based on a number of factors including the risk profile of the manufacturing
environment and the complexity of the plant. Ultimately, the certification cost as a percent of total
manufacturing costs is minimal…a small fraction of total manufacturing costs. The net benefit
(increased consumer confidence in their products) to manufacturers will be far greater than the costs.
The following costs are involved in GFCO certification. There are no other fees or charges to
companies for certification.

GFCO has:

• NO APPLICATION or DESK AUDIT fees
• Audit fees – a flat rate is charged for audits. An audit fee is associated with each plant
  producing certified gluten-free products. The rate may be reduced for companies with multiple
  plants. The audit fee in the US is $600.
• Inspector travel expenses – GFCO inspectors group audits to reduce costs to companies, and
  when applicable will combine them with other audits (HACCP, GFSI, GMO, Organic, etc.)
•  Certification/Licensing fee – these are flat rates for certification or licensing, based on risk. It
  is not based on the number of SKU’s, Brand sales, etc.

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 meeting strict standards. Audits conducted
by the GFCO Inspectors, also verifies that the company is providing and meeting high standards in
producing their product. Manufacturers save valuable time and resources that would have been spent
answering questions regarding the gluten-free status of their products.

Is certification given to products?
Yes. Individual products meeting GFCO standards can be certified. Manufacturers producing certified
products undergo an audit in each location certified products are produced.

Can a manufacturing plant be certified?
No. GFCO only certifies products made in facilities whose practices meet our Standard requirements,
but we do not certify the plant itself.

Can I manufacture GFCO certified products in a rental/incubator/commissary kitchen?
Yes. The rental kitchen itself cannot apply for certification, but any companies manufacturing in the
facility can apply for separate product certifications. In order to obtain product certification in a rental
facility, the company that does the manufacturing must be present at the audit so that their production
practices can be audited.

Can I certify raw materials that are simply re-packaged prior to sale?
In some cases, yes. GFCO will only certify low risk, non-manufactured products for re-packaging
facilities.

Can a manufacturing plant produce both certified products and products not certified by
GFCO?
Yes. Co-manufacturers of certified products have processes and procedures in place that maintain
the integrity of certified products produced in those facilities. GFCO has no responsibility or
knowledge of the business relationships between co-manufacturers and their clients, unless they are
GFCO certified.

Can I claim to be processed in a GFCO certified manufacturing plant IF I do not have GFCO
certification?
No. We do not certify manufacturing facilities, and products that are not certified by GFCO may not
create an implied relationship with GFCO or imply their products’ safety by using a manufacturer of
GFCO certified products. GFCO only has the ability to monitor production practices of products
carrying the GFCO logo as we are a third party certifying body. We are NOT a government regulatory
body and cannot enforce actions on companies producing products that are not certified through our
organization.

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.

AUDITS

Is an audit required for all of my manufacturing plants?
Any location that produces GFCO-certified products must be audited. The audit frequency is
determined by the risks associated with the ingredients, manufacturing facility and products. Audits
may be announced or unannounced.

Is a dedicated production facility required?
No. While a dedicated gluten-free facility greatly reduces the risk of contamination, it does not
eliminate all risk, such as those related to ingredient procurement and validation.

Are dedicated lines important?
The type of production process, cleaning methods and other factors are important factors while
assessing if a gluten-free product can safely be run on the same line that gluten-containing products
are run on. GFCO inspectors assess the risk for cross contamination during their audits.
Manufacturers may be required to test equipment to document the cleaning process is adequate to
allow the safe production of gluten-free products on the same line. Dedicated lines and equipment
used for gluten-free products greatly reduces the chances of cross contamination.

What type of process must companies have in place to meet GFCO requirements?
GFCO reviews the manufacturer’s SOPs related to ingredient purchase and review, production,
cleaning, allergen training, recall programs, packaging of gluten-free products, etc. GFCO reviews
GMP and HACCP programs, if available, as well as other information reviews. Based on the review
of these documents, the site audit and other factors, GFCO may identify departures from the GFCO
Standard that must be corrected before certification can be issued. GFCO defines minimum product,
equipment and raw material testing requirements.

What are the testing requirements?
GFCO requires that ingredients and finished products must be at 10 ppm or less gluten. GFCO
identifies and assesses a risk factor on all raw materials. The risk factor is determined by the potential
risk of the raw material being cross-contaminated, type of ingredient, history with supplier, testing and
other documentation. The risk factor assigned determines the required testing frequency of raw
materials before they can be uses in production. Frequency or need for equipment testing is
determined by factors such as, but not limited to, risk of cross contamination, type and validation of
cleaning processes, and type of equipment and production. Finished product testing is always
required. Frequency is determined by production frequency, product, facility and ingredient risks.

How does GFCO audit manufacturers for compliance?
GFCO uses fully-trained qualified auditors to conduct plant audits. A standardized audit report is filed
with GFCO. A review of the audit report determines if certification will be issued and/or what
requirements must be fulfilled prior to granting certification.
GFCO requires quarterly reporting of testing results by companies to GFCO and all results are
reviewed by the GFCO Quality Manager. Testing results out of spec for GFCO certification require a
Corrective Action to be documented and submitted. GFCO does random Point of Sale (POS) testing
and investigates consumer or other complaints.
During the site audit, the auditor will evaluate the process from beginning to end, including receiving,
storage, staging, production, cleaning and sanitation, air systems, training, testing, packaging,
labeling review, corrective action programs, etc.

Does GFCO audit my labels?
GFCO reviews labels for the use of the certification logo. GFCO is not a governmental regulatory
agent and does not have authority to review and approve labels for meeting labeling requirements.

TESTING

How often is a product inspected or tested?
The number of times a product must be tested depends on a number of factors including the products
being certified, the type of plant, etc. Risk of potential for cross contamination with gluten 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. Product
testing by the manufacturers is required at the location of production on a regular basis. Minimum
testing requirements are included in the certification contract.

How often does GFCO check products for compliance?
GFCO does random POS testing on a representation of products. Products with the highest risk of
cross-contamination are tested more frequently. GFCO absorbs the cost for this testing. GFCO also
requires quarterly reports on testing from all companies and manufacturing plants.

How often is testing of equipment required?
Testing of equipment is based on the equipment’s use, function, and identification of high risk areas.
GFCO encourages the use of test kits testing at 10 ppm or less be used for testing equipment.

Is the test that measures the lowest level of gluten always the best test to use?
Not necessarily. When identifying testing kits for use in the GFCO program, the GFCO Scientific
Team takes into consideration a number of factors including validation of testing procedures by
scientific authorities, such as AOAC and AACC, sensitivity and specificity, use with the specific
product, etc. Companies are recommended to validate the testing method used for their products.

What testing methods do GFCO recommend?
GIG provides companies with a document of testing kits and methods that have been GFCOapproved
for use as part of our certification program. GFCO requires the use of third-party validated
test methods and certified labs. GIG does not endorse a specific testing method or lab.

Do ingredients have to be tested?
GFCO assigns a risk assessment to all ingredients. High risk ingredients are required to be tested
prior to use in a certified product. Some materials, such as grain products, may require increased
testing if they are not certified gluten-free by a GFCO-recognized certification program, before being
used in production.

FDA REGULATION

How does the FDA’s Gluten-Free Labeling ruling affect or differ from the GFCO program?
On August 5, 2013 the FDA finalized regulation for gluten-free labeling went into effect. This ruling
requires that any product labeled “gluten-free” must not contain any ingredient from wheat, rye or
barley, and must not contain greater than 20 ppm gluten. This is a passive regulation, meaning that
the FDA will not make a coordinated effort to monitor gluten-free claims. In contrast, GFCO
certification involves the active review of manufacturing processes and gluten levels in ingredients
and finished products to ensure consumer safety, and has set an upper limit of 10 ppm gluten. While
the programs differ, the FDA ruling does not affect the GFCO certification program.

TTB AND GLUTEN-FREE ALCOHOL

Can alcohol and beer be certified gluten-free?
The Alcohol Tax and Trade Bureau (TTB) will not allow products made from ingredients that contain
gluten-containing grains to be labeled as “gluten-free.” Because TTB is concerned about the potential
health consequences associated with the consumption of gluten by individuals with celiac disease
and, because there are currently no scientifically valid testing methods available to accurately
measure the gluten content of fermented products, they will only allow these products to be labeled
with a statement that they were processed to remove gluten but that the product may still contain
gluten. “Gluten-Free Beer” that does not meet the definition of beer, as established by the TTB, is
regulated by the FDA. The TTB has posted an interim letter that will allow products made from
ingredients that do not contain gluten to be labeled as “gluten-free,” if the producer takes appropriate
precautions to ensure against the introduction of gluten into the product during processing. The
Revised Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wine,
Distilled Spirits, and Malt Beverages, can be found here – http://www.ttb.gov/rulings/2014-2.pdf. For
more information on TTB, please visit their Web site at www.ttb.gov.