Effective Allergen Management: Ensuring Gluten-Free Safety in Your Production Line

Gluten-free products aren’t new to the industry anymore, in fact, in 2013, the FDA released its final rule defining gluten-free for food labeling. While the gluten-free label remains a voluntary claim that manufacturers can include or not, the FDA has specific requirements determining what the claim actually means. Manufacturers are also responsible for presenting the claim in an accurate and non-misleading way, similar to an allergen.

What Does Gluten-Free Mean?

Under both the FDA and Canadian Food Inspection Agency (CFIA), any foods declared gluten-free must contain less than 20 parts per million (ppm) of gluten. This parameter was established by CODEX, an international food standards body that provides guidelines, including those on gluten-free foods. The international authority determined 20 ppm to be safe for the majority of individuals with Celiac disease. Besides containing less than 20 ppm of gluten, the FDA permits the labeling of a food as gluten-free if it does not contain: wheat, rye, barley, or crossbreeds of these grains; an ingredient derived from these grains that has not been processed to remove gluten; or, an ingredient derived from these grains that has been processed to remove gluten but still contains more than 20 ppm of gluten.

How Does This Affect Food Manufacturers

With an estimated 1% of the global population suffering from Celiac disease, and an estimated 0.5-6% (some estimates go as high as 8%) having non-celiac gluten sensitivity (NCGS), the demand for gluten-free products has never been more evident. The increasing awareness of these conditions, coupled with a broader consumer trend toward gluten-free diets for health and wellness reasons, makes it clear that the gluten-free food product market continues to grow. Food manufacturing today is no longer just meeting a niche demand; they are tapping into a rapidly expanding market that caters to a diverse consumer base. While offering gluten-free products helps to ensure the estimated 3 million Celiac disease sufferers in the U.S. have access to a variety of affordable and safe food choices, it also caters to the additional members of the population who have NCGS or actively avoid gluten.

Approximately 90 million Americans and 9 million Canadians maintain a gluten-free diet. An estimated 6% of the population has NCGS, which also requires them to avoid gluten to prevent or minimize adverse health effects caused by diet. Another 22% avoid gluten voluntarily. In total, it is estimated that over half the North American population regularly purchases gluten-free products.

Many food manufacturers have caught on to this growing need for more gluten-free choices. Recent data shows that the gluten-free food market continues to expand rapidly. In 2022, the gluten-free food market was valued at approximately $6.45 billion and is expected to grow at a compound annual growth rate (CAGR) of 9.8% from 2023 to 2030. 

The gluten-free market has proven its popularity and necessity within the food and beverage industry. However, going gluten-free presents added responsibilities that demand appropriate preventive controls and proactive management strategies.

What Do Gluten-Free Regulations Mean for Food Companies?

Allergens remain the leading cause of food recalls in both the U.S. and Canada, underscoring the ongoing challenge of effective allergen management in complex food manufacturing environments. In particular, undeclared allergens accounted for 63% of all food recalls in the U.S. in 2023, reflecting the stringent regulatory landscape and the high risk of cross-contamination during production processes. While gluten, specifically, is less frequently the direct cause of recalls compared to other allergens, it still plays a significant role when combined with wheat. However, in Canada, there were 64 identified recalls due to “gluten contamination” between 2018 and 2022. 

To ensure integrity and compliance with gluten-free specifications, a gluten-free management program must be developed and implemented throughout the supply chain. Effective management of a gluten-free program should encompass Hazard Analysis and Critical Control Points (HACCP)-based methodologies. At the most basic level, this includes the identification, prevention and control, and declaration of gluten.

Considerations for Mitigation

Whether moving towards becoming a completely gluten-free facility or preparing for gluten-free labeling on a specific product or product line, food companies should take steps to mitigate the risks associated with gluten in their facilities.

• Re-examine relationships with suppliers: One preliminary step food companies can take is to reassess vendor management. Consider supplier history and performance in the areas of audits, quality, safety, and testing to determine whether continuing to do business with a particular supplier will help or hinder successful gluten-free management.

• Become knowledgeable on products: To determine a facility’s risk factors, it is necessary to first develop an in-depth understanding of where gluten may be found in its products or ingredients.

• Gluten proteins are commonly found in bread, cereal, pasta, cakes, and many other foods containing barley, rye, wheat, kamut, spelt, or triticale. Gluten is also defined as any modified gluten protein or protein fraction derived from any of the aforementioned grains.

• Obtain certification: Completing a gluten-free certification program can help companies develop a clear and effective gluten management program and reduce risks. Certification from a reputable gluten-free program can also aid in building trust and loyalty among customers seeking gluten-free products, and it can also help products go to market effectively by supporting brand credibility.

While this is by no means a comprehensive list of actions food companies can take to support effective gluten-free practices, it does provide a solid foundation on which a robust gluten management program can be built.

4 Steps for Creating an Effective Gluten-Free Management Program

Beyond providing a variety of safe and easily accessible food choices for people with Celiac disease, gluten-free foods are becoming a highly sought-after choice among many individuals across the world. Yet, making the shift towards becoming gluten-free requires putting a comprehensive management program in place first.

Because gluten can be characterized as an allergen for individuals with Celiac disease, a gluten management program very closely resembles an allergen control SOP. While programs will need to be tailored to fit the precise processes and supply chain practices from one facility to the next, the following framework can be used for establishing a baseline for proactive gluten-free management.

1. Identify Risks

A thorough risk assessment is the first step in any comprehensive gluten control management system. Risks should be assessed across every facet of your supply chain, as well as your internal operations. From receiving to packaging and shipment, identify the ingredients, processing aids, and products that contain or do not contain gluten, noting all paths of gluten in your facility. Assess key points including receiving, storage, mixing and processing, and labeling. Facilities processing gluten will need to identify risks for cross-contamination, mislabeling, and any other potential issues that could arise.

2. Develop Controls

Once risks have been identified, the next step is to put controls in place to mitigate these risks. The greatest risks call for the most rigorous planning. To reduce the potential of undeclared gluten, the following tactics should be implemented: 

• supplier and ingredient control, 

• controlled onsite food storage, 

• segregating processing, and/or 

• handling of products or ingredients, 

• specified equipment selection, and 

• use and control of labels and packaging.

For certified companies, audits are also an effective means of ensuring controls are being developed and implemented properly.

3. Train Employees

Once a gluten control program has been developed, personnel must be properly trained in every aspect. Although cross-contamination is a central area of focus on which employees must be trained, sanitization processes and rework procedures must also be addressed thoroughly. Educating employees on the risks associated with gluten contamination should also be a pillar of every training program.

4. Perform Continuous Monitoring

Lastly, food manufacturers and processors must develop methods for routinely monitoring the effectiveness of their gluten control procedures. This includes determining the frequency with which allergen control efforts should be analyzed, as well as the metrics that will be used to gauge performance. Upgrading to an automated food safety platform can help monitor performance using real-time analytics.

It’s clear that the demand for gluten-free options is here to stay, and by responding by either becoming an entirely gluten-free processing facility or offering a line of gluten-free products, food companies may be able to secure a more competitive place in the market and expand their customer outreach. With the approach outlined above, companies can also ensure regulatory compliance and brand credibility for long-term success.

Ensure Compliance and Boost Efficiency with SafetyChain

Maintaining strict compliance and ensuring the integrity of your gluten-free production is critical. SafetyChain Software offers a comprehensive solution that empowers food manufacturers to seamlessly manage, monitor, and verify gluten-free production processes.

With SafetyChain, you can:

• Track Every Batch: Maintain full visibility of your production process with real-time tracking, ensuring that every batch meets gluten-free standards.

• Simplify Compliance: Stay ahead of regulatory requirements with automated documentation and reporting features, reducing the risk of incorrect labels, lost documents, and poor audit scores.

• Enhance Quality Control: Utilize SafetyChain’s robust quality control tools to conduct thorough inspections, tests, and audits, all within a single platform.

• Respond Quickly to Issues: Receive instant alerts for any deviations in your gluten-free production, enabling rapid response and minimizing potential cross-contamination risks.

Ensure your gluten-free products meet the highest standards with SafetyChain Software.