FDA Gluten-Free Labeling Rule, August 14, 2014, and Certification through Gluten-Free Certification Organization (GFCO), Gluten-Free Certification Program (GFCP), and National Celiac Association (NCA)
- The FDA and Gluten-Free Certification Bodies are all committed to providing gluten-free product and ingredients necessary for those with allergen conditions making food products with gluten medically prohibitive.
- Product, ingredient, and system certification was developed for use in all organizations who have chosen to provide food products or ingredients that meet the needs of a consumer base that have allergens to gluten. This involves selection of the proper testing / analysis methods to ensure that the organization can achieve certification and meet FDA Gluten-Free
The FDA has established criteria for the level of gluten in food or ingredients to ensure safety. The FDA Gluten-Free Labeling Rule requires that product test results indicate less than 20-ppm gluten content to achieve certification and has established rules for use of the Gluten-Free Label upon successful audit certification. Dependent upon the certification body chosen, the requirements and levels may vary but all must meet the 20-ppm rule.
This requires analysis and testing to ensure compliance. This achieved by implementing procedures to enable successful and consistent passing of Product Audits. Third-party product audits may consist of a plant tour, inspections / tests of product and audit for system compliance. These audits usually last ½ to 1 day.
Certification can be achieved through organizations that in some cases have more stringent requirements, that still ensure compliance to the FDA regulations, and provides the organization with a Gluten-Free Management System (GFMS) to instill confidence in the level of quality in the product.
Gluten-Free Certification Organization (GFCO) provides third-party certifications / audits to meet FDA requirements. GFCO is an outgrowth of the Gluten Intolerance Group (GIG). which serves as a non-profit to assist those with gluten disorders such as Celiac Disease, certifying companies that provide gluten-free products and supplements. GFCO audits include the following provisions:
- Annual On-site audits / inspections.
- Additional unannounced audits or testing of retail products by the company in stores.
- System audits for regulatory compliance to government requirements for Good Manufacturing Practices (GMPs), Allergen Compliance, and proper Labeling.
- Finished Product and Ingredients must meet a more stringent requirement of 10-ppm or less gluten content.
- Equipment testing for potential for contamination
Gluten-Free Certification Program (GFCP), begun by both the Canadian Celiac Association and the Allergen Group, provides a more extensive system for voluntary third-part certifications with the goal of providing gluten-free product for the food chain. The GFCP audit consists of the following elements:
- Annual on-site audits / inspections.
- Inspections / audits of the organizations for –
- Management of supply chain for ingredients.
- Employee competency, training and compliance to Good Manufacturing Practices (GMPs).
- Potential for cross-contamination.
- Sanitation and cleaning.
- The organizations Testing Plan.
- Operations control.
- Third-party auditors are certified / licensed by Gluten-Free Certification Program (GFCP), International Organization for Standardization (ISO), or the National Celiac Association (NFCA).
National Celiac Association (NCA), provides educational services for those with Celiac Disease and Gluten Disorders. In service to this group NCA provides certification to companies that manufacture, package, or handle product intended to be gluten and allergen free. Certification ensures:
- Product free or not contaminated by barley, rice, wheat, oats and any similar combinations / derivatives.
- Certification testing of product to ensure that no evidence of gluten is detected in product
Who Should Implement a Gluten-Free Management System (GFMS) through GFCO or GFCP to Achieve Product Certification to the FDA Gluten-Free Labeling Rule?
- Any facility wanting to provide assurance for customers products are safe for consumption to those with Gluten Intolerance that could create a medical hazard for the consumer and demonstrate the capability to provide product or ingredients that are Gluten-Free.
- Any facility desirous of having a strong marketing tool to showcase their commitment to meeting consumer desires for Gluten-Free products based on a sector of the market with Gluten Intolerances.
- All businesses, operations, and organizations needing disciplines in place to ensure consistent product level results in Gluten Testing.
- Any organization with product lines including those that contain both Gluten and Gluten-Free Products needing rigorous controls to prevent cross-contamination / comingling of product.
Process for Getting Gluten-Free Management System (GFMS) Certification through GFCO or GFCP to Achieve Product Certification to the FDA Gluten-Free Labeling Rule:
- Achieving Gluten-Free Certification to the FDA Gluten-Free Labeling Rule as a Gluten Free Management System (GFMS) or attaining a Gluten-Free Certification Program (GFCP), starts with preparation a well-developed Quality Control & Testing Plan.
- Consultants proficiently qualified in developing a comprehensive, Gluten-Free Management System (GFMS) to meet the chosen certification body product and ingredient requirements is essential in development of a system to provide food products or ingredients that meet the needs of a consumer base that have allergens to gluten.
- Selection of the proper testing / analysis methods and implementation of a Quality Control & Testing Plan is required to ensure that the organization can provide product that consistently achieves all requirements and the FDA Gluten-Free Labeling Rule, 20-ppm or better (dependent on certification body) requirements.
- QSE consulting firm provides the techniques for implementation, and trains organization’s internal auditors to become competent to perform internal audits/tests of product and systems to meet the FDA Gluten-Free Labeling Rule.
- Management needs to ensure the facility is physically prepared to provide clean, cross-contamination free production.
- Once the facility passes the certification body and the FDA Gluten-Free Labeling Rule compliance audit successfully, the certification body issues the compliance certificate to the organization.
- The organization may then use the Gluten-Free Label.
- Quality Management Consultants can prepare your facilities for Gluten-Free Testing and Certification through implementation of a simplified, thorough Gluten-Free Management System.
- QSE can provide guidance in selection of the Certification Body and Testing Services that best fit your company needs and marketing strategy.
- QSE Consultants are experienced in assisting small, medium and large organizations in developing, training, implementing, and maintaining a compliant / documented / consistent Gluten-Free Management System. It is not a plug and play system, but one designed specifically to fit your organizational needs.
- Provision of internal audits to ensure product and system meets all requirements and employees prepared for certification and interfacing with auditor.
- QSE consultants will ensure that certification is successfully achieved upon initial audit by the certification body.
- QSE provides guidance in:
- Implementation of Gluten-Free applications for those providing only this type of product or those that produce multiple product lines requiring assurance that cross-contamination is controlled and risk of gluten or allergen contamination eliminated through identification of potential contamination points in processes and equipment.
- Development of a rigorous Quality Control Plan that minimizes hazards and ultimately benefits both organization and consumer.
- Implementation of testing at appropriate stages to prevent contamination.
- Establishment of an employee training program that gives results
- Employee involvement to achieve successful implementation.
- Education on control of cross-contamination, Good Manufacturing Practices (GMPs), sanitation/cleaning, identification of glutens / allergens
- Proper training in hazard assessment and application of testing for identified hazard.
- Procedure for prevention of cross-contamination or elimination of glutens / allergens.
- Education on contaminants, Good Manufacturing Practices (GMPs), & sanitation/cleaning procedures.
- A robust system that trains and compels employees to understand and adhere to defined roles, responsibilities, procedures and controls.
Why Is Consulting Required for Gluten-Free Management System (GFMS) Certification; Gluten-Free Certification Organization (GFCO), or Gluten-Free Certification Program (GFCP) for the FDA Gluten-Free Labeling Rule?
- A good consultant firm can provide detailed explanation on the intent and properly define and implement the system to meet requirements.
- A comprehensive Gluten-Free Management System can create confidence in customers and provide answers to all questions from certification auditors.
- An experienced Gluten-Free consulting firm provides experience in the techniques for developing and implementing the GFMS.
- Consulting firm such as QSE provides audit and testing services to help the facility verify the accuracy and adequacy of the system and provide accurate levels of gluten in product.
- Annual surveillance audits are conducted to ensure implementation effectiveness of established GFMS.
- Thoroughness of preparation and ease of FDA Gluten-Free Labeling Rule certification achievement by utilizing all of QSE’s 10-Step Approach.
- Quality Systems Enhancement Inc. (QSE) is a Premier Consulting, Auditing and Training firm with over 27 Years’ experience in assisting with any Gluten-Free Standard, ISO Standard, Sector Specific Standard, AISC Standard and all Food Safety
- QSE provides On-Site and On-line Training for all Gluten-Free Certifications to ensure Awareness of Requirements and Effective Implementation along with internal Product/System Auditing.
- QSE’s Consultants have helped over 800 facilities to earn multiple ISO, Food Safety, Gluten-Free, and many other certifications.
- Over 98 % of QSE customers passed certification audits with no nonconformity first time around. QSE has a 100 % success rate in obtaining certifications for its customers.
- Unlike our competitors, QSE provides a unique, comprehensive, evidence based, simplified documentation system comprehensively encompassing all requirements to achieve Gluten-Free Compliance which is easy to implement and provides product and system compliance results to earn Gluten-Free Certification.
- QSE Consultant’s Gluten-Free Audits are an effective management tool to run any business processes to enhance Bottom-Line
- QSE designed templates are tried and tested for thorough coverage of all standard requirements, accuracy and correctness and provide objective evidence during internal audits and ISO certification/compliance audits.
- QSE’s simplified Gluten-Free System is evidence and result based, and is easy to implement, easy to use and easy to audit. If required the QSE System can be integrated with other ISO or Food Safety Management System Standards.
- QSE‘s evidence-based system with proven lists, forms and tables results in certification with minimum or no nonconformities.
- QSE utilizes competent ISO & Gluten-Free Auditors to conduct product and supply chain material audits
President QSE, Baskar Kotte is an original and an active member of ISO/US TAG/TC 176, the Technical Committee that originally developed the ISO 9000 family of standards, ISO/US TAG/TC 207 which developed the ISO 14000 family of standards, ISO/US TAG/ TC 301 (TC 242) which developed ISO 50001 and ISO 19011 the Guiding Standards for Auditing. Mr. Kotte also participated and provided input to the development of the current ISO, ISO 14001:2015, ISO 45001:2018 family of Standards and ISO 19011:2018 revised standards.
Benefits of Gluten Free Management System (GFMS) Certification; Gluten-Free Certification Program (GFCP), and Using the FDA Gluten-Free Labeling Rule:
- Benefit through identification of hazard points and high-risk ingredients to manage the risk of cross contamination.
- Discipline implemented to identify High-Risk items / Area / Equipment and Quality Control Plan to control the risk
- Additional Requirements such as criteria for allergen levels that are not a part of the FDA Gluten-Free Labeling Rule.
- Gluten-Free Certification provides consistency and confidence organizational ability to provide consistent Gluten-Free product
- Benefits of quality / compliant final product for the organization and the consumer.
- Benefit of all manufacturers having to abide by the same rules
- Bottom Line Benefits to ensure satisfied customer and meeting needs for those with –
- Celiac disease
- Auto-immune disorders
- Health conditions causing loss of lining within the small intestine and the risk of other serious health conditions.
- Concern that product being purchased is gluten-free and certified by a trusted third-party certification body