FAQ: Gluten-Free Certification Organization (GFCO)
ABOUT CONSUMERS CERTIFICATION MANUFACTURERS RESOURCES
What is the mission of the Gluten-Free Certification Organization?
The Gluten-Free Certification Organization (GFCO) was established in 2005. 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 structure of GFCO?
GFCO uses an Advisory Scientific and Business Board to develop and review program standards, processes and procedures. GFCO consults with independent experts in medicine, food safety, manufacturing and laboratory testing procedures.
Auditors are qualified, third-party auditors with a minimum of 3-5 years in food manufacturing QC processes, auditing processes, safety audits, or safety and quality control consultants to the food industry. GFCO partners with independent auditors and ISO-certified auditing agencies.
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 GF.
How many companies utilize the GF logo in N. America, the world?
(2/2013) GFCO currently certifies 13,000 products, sold in 5 countries and expanding. Audits are conducted in 15 countries.
What percentage of the gluten-free market uses the GFCO certification logo?
In 2012, GFCO certified about 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 auditor training and demonstration of knowledge proficiency.
GFCO auditors undergo a review process of their auditing skills at least annually.
GFCO provides 1:1 and group education programs and consultations.
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 less than 10-ppm 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 Association of Analytical Communities (AOAC) and the American Association of Clinical Chemistry (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 complaint process in place. Contact GFCO at admin@GFCO.org. The process includes:
A request to have the remaining product sent to GFCO for testing.
Purchase information, including date, location, product identification.
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 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.
What is GFCO’s standard for Gluten?
GFCO’s standard is 10 ppm or less gluten in finished products.
Can oats be certified?
Yes. Oats certified GF by GFCO must meet the GFCO standard of being 10 ppm gluten or less.
Can products with wheat starch be certified?
Yes, as long as the finished product is 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?
The GFCO works with auditors who have years of experience performing Hazard Analysis and Critical Control Point (HACCP) Compliance, organic, Global Food Safety audits, and kosher audits of companies worldwide.
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.
How is gluten-free certification done?
Certification is a yearly process based on ingredient review, on-site inspection and ongoing product testing. Some facilities require multiple inspections throughout the year.
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 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.
The following costs are involved in GFCO certification. There are no other fees or charges to companies for certification.
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 $500.
Auditor travel expenses - GFCO auditors group audits to reduce costs to companies, and when applicable will combine them with other audits (HACCP, GFSI, GMO, Organic, etc). Licensing/Certification fee – this is a flat rate for certification, based on risk, # of plants, and private labels. It is not based on the number of SKU’s, Brand sales, etc.
GFCO offers a Small Business Offer to very small companies with 5 or less products to be certified. This is the only situation when a ‘per SKU’ pricing matrix is used.
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. Inspections conducted by the GFCO auditors, 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?
Yes. Manufacturers who produce gluten-free products can certify the facility. Certified manufacturers may produce GFCO-certified products for their clients if specified contract terms are met.
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.
Is an audit required for all 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. Manufacturing plants will have a minimum annual audit, but may be audited more frequently. 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.
Are dedicated lines important?
Sometimes. The type of production process, cleaning methods and other factors are important in accessing if a gluten-free product can safely be run on the same line that gluten-containing products are run on. GFCO auditors assess the risk for cross contamination during their audits. Manufacturers may be required to test equipment to document that lines can be cleaned adequately and safely used to produce gluten-free products. 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 ingredients, production, cleaning, allergens, training, recall program, packaging of gluten-free products, etc. GFCO reviews GMPs, HACCP, and GFSI programs, as well as other auditor reviews. Based on the review of these programs, the site audit and other factors, GFCO may identify requirements that must be implemented before certification to be issued. GFCO defines minimum product, equipment and raw material testing requirements.
GFCO standards are that 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 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 frequency of testing of raw materials before it 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. GFCO will perform audits annually or more frequent and they may unannounced.
How does GFCO audit manufacturers for compliance?
GFCO uses 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 or what requirements must be fulfilled prior to consideration of certification.
GFCO requires quarterly reporting of testing results by companies to GFCO. All results are reviewed by GFCO staff. Testing results out of spec for GFCO certification require a Corrective Action to be documented. GFCO does random Point Of Sale (POS) testing and follows up on 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.
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. 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.
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.
How often is testing of equipment required?
Testing of equipment is based on identifying and testing high risk areas of the equipment. 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 for their products.
What testing methods do GFCO recommend?
GIG provides companies with a document of testing kits and methods that have been GFCO-approved for use as part of our certification program. GFCO encourages 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.
How does the FDA's proposed Gluten-Free Labeling ruling 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, balanced by reasonable application by the manufacturer.
The FDA was 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. To date, a final ruling is not in place. Therefore in the US, there is no legal definition for gluten-free. The Gluten Intolerance Group (GIG) monitors and participates in the FDA meetings regarding this matter.
GFCO gluten-free standards will meet or exceed the FDA final rulings. More details are available at the FDA Gluten-Free Labeling Proposed Rule web site: http://www.fda.gov/food/labelingnutrition/foodallergenslabeling/guidancecomplianceregulatoryinformation/ucm111487.htm
Once the FDA final ruling is announced, GIG and GFCO will review the ruling and evaluate its impact on the GFCO certification program.
What impact will the FDA ruling have on GFCO?
The Scientific Team for GFCO will review the final 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?
Our goal is to provide a certification program that has higher standards in order to give consumers greater confidence in the certification process. At this time we do not anticipate changing the program standards.
How will the FDA testing recommendation affect the testing methods used by GFCO?
GFCO scientific and legal team will review this when FDA puts out their final ruling. The testing methods outlined in the proposed document are methods the FDA as identified as methods they would use in testing products. The proposed ruling does not mandate that companies test products, however they do have to be able to document their products meet the definition established.
GFCO believes there is a role for the use of both qualitative and quantitative testing methods. A number of kits are available for testing for gluten. Various test assays may have strengths or weaknesses unique to the assay used. Therefore is may be useful to use different assays in conjunction with each other to determine the source of contamination. Quantitative Elisa testing is the most accurate testing methods for gluten.
Will the FDA ruling apply to products regulated by the USDA?
No. The FDA ruling does not apply to USDA-regulated products.
Will the FDA ruling make it more difficult or costly to become certified?
No. The FDA ruling should have little or 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.
TTB and GF Alcohol
Can alcohol and beer be labeled gluten-free?
TTB will not allow products made from ingredients that contain gluten 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 Food and Drug Administration (FDA) is currently engaged in rule-making regarding gluten labeling. Upon issuance of a final rule by FDA, TTB will evaluate whether the interim policy set forth in this ruling should be revised.
TTB Ruling 2012-2 may be found on our Web site at: http://www.ttb.gov/rulings/2012-2.pdf
For more information on TTB, please visit our Web site at www.ttb.gov.