Defining a Gluten Free Food
In the US, the FDA defines a gluten-free product as one that contains less than 20 parts per million (ppm) of gluten).
Gluten-free Claim vs Certification
A gluten-free claim is a voluntary statement by the manufacturer of the product, asserting that the product meets the regulatory definition of “gluten-free” (i.e. less than 20 ppm of gluten in the US). This claim is self-regulated, meaning that the manufacturer is responsible for ensuring the product meets the criteria for being gluten free, and adheres to proper manufacturing practices to prevent cross-contamination. A gluten-free claim should be suitable for those with gluten sensitivities or celiac disease, however it does not provide third-party verification or assurance of the manufacturing processes and gluten content.
A gluten-free certification is a seal or logo granted by an independent, third-party organization that verifies the product meets strict gluten-free standards, often more stringent than the regulatory definition. To obtain a gluten-free certification, the manufacturer undergoes a thorough evaluation, including an assessment of their manufacturing practices, testing of products for gluten content, and sometimes even periodic audits to ensure ongoing compliance. The certification provides added credibility and assurance to consumers, especially those with celiac disease or gluten sensitivities, who rely on strict adherence to a gluten-free diet. The presence of a gluten-free certification on a product implies a higher level of scrutiny and confidence in the product's gluten-free status.
What food products may be labeled gluten-free?
A food product regulated by the FDA may be labeled gluten-free if:
- It is inherently gluten-free, meaning it does NOT contain wheat, rye, barley, or their crossbred hybrids like triticale (a gluten-containing grain) OR
- It does NOT contain an ingredient that is derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour) OR
- It does NOT contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food
When is a gluten-free certification needed?
A gluten-free certification is not always legally required, but can provide added credibility and assurance to the customer. This certification is particularly important if you are:
- Targeting a niche market or selling to customers with celiac disease or gluten sensitivities, as they require strict adherence to a gluten-free diet.
- Producing products with a higher risk of cross-contamination, such as those made in shared facilities or with equipment that processes gluten-containing ingredients.
- Exporting your products to countries with strict gluten-free regulations or where gluten-free certifications are mandatory.
What does this mean in terms of my manufacturer?
If you want/need to certify your product gluten free, you need a facility that can offer that certification.
However, the gray area arises when you want to make a gluten-free claim. You do not necessarily need a dedicated gluten-free facility to make a gluten-free claim - you just need to meet the regulatory definition, which in the states is under 20 ppm of gluten.
If your contract manufacturer processes both gluten-free and gluten-containing products, you can discuss the following practices with your co-man as ways to minimize cross-contamination and maintain the gluten-free integrity of your product:
- Segregation: Designate specific areas, equipment, or production lines for gluten-free products to minimize contact with gluten-containing ingredients.
- Cleaning and Sanitization: Implement strict cleaning and sanitization procedures for equipment, utensils, and surfaces that come in contact with gluten-free products. Thoroughly clean and sanitize equipment between processing gluten-containing and gluten-free products.
- Employee Training: Train employees on proper handling procedures for gluten-free ingredients and finished products, as well as the importance of preventing cross-contamination.
- Ingredient Storage: Store gluten-free ingredients separately from gluten-containing ingredients to prevent accidental contamination.
- Scheduling: Schedule production runs of gluten-free products at the beginning of the day or after a thorough cleaning of the production area to minimize the risk of cross-contamination.
- Testing: Regularly test your gluten-free products for gluten content to ensure they meet the regulatory requirements and to identify any issues with cross-contamination.
- Quality Control: Implement a comprehensive quality control program to monitor and maintain the gluten-free status of your products.
Dedicated gluten-free contract manufacturers are less readily available and often come with other limitations (restriction of other allergens, etc). While a dedicated gluten-free facility can provide an additional level of assurance for consumers and reduce the risk of cross-contamination, it is not strictly necessary for making a gluten-free claim, as long as you follow best practices and ensure your product meets the gluten-free requirements outlined by the regulatory body in your region.
The FDA has further information on Gluten Free products:
