With food allergies on the rise—impacting millions of children and adults globally—clear and accurate allergen labeling has never been more essential. For food and beverage manufacturers, meeting allergen labeling requirements isn’t optional—it’s a fundamental responsibility. But there’s one gray area that continues to cause confusion: precautionary allergen labeling (PAL). Those familiar “May contain” statements might seem like a safe catch-all, but when used improperly, they can erode consumer trust, create regulatory risk, and dilute the purpose of allergen warnings altogether.
Why PAL matters (when it’s used correctly)
Precautionary allergen labeling is designed to inform consumers of potential allergen cross-contact during manufacturing. Cross-contact, also known as cross-contamination, can happen when supposedly allergen-free foods come into contact with allergen proteins during processing. This might occur if products share the same equipment, a facility uses airborne allergen particles, or ingredients are stored improperly.
While PAL is voluntary in regions like the US, Canada, UK, and the European Union (EU), it must be applied responsibly. It’s not a catch-all safety net to shield brands from liability. When used improperly, PAL can have far-reaching consequences.
- For consumers with allergies: Overusing PAL limits food choices unnecessarily or leads shoppers to ignore warnings altogether, putting their safety at risk.
- For businesses: Misuse can result in regulatory violations, product recalls, or damaged consumer trust.
PAL is not a substitute for good manufacturing practices
Across countries that permit PAL, governing bodies such as the FDA, Health Canada, and EU regulators agree on one thing: PAL should never replace good manufacturing practices. Manufacturers must take every possible precaution to avoid cross-contact before considering the use of a “May contain” statement.
This means running thorough risk assessments and implementing robust allergen management protocols. For example, some risks you’ll need to evaluate include shared equipment, ingredient sourcing, employee hygiene, air particle contamination during processing, and even transport and packaging.
Without a documented risk assessment that proves there’s still a possibility of cross-contact after all measures have been taken, adding PAL is not just unnecessary; it may be misleading.
How to ensure compliance and avoid PAL missteps
No matter where your products are manufactured or sold, it’s essential to understand the allergen labeling regulations in those regions. Here are five best practices to follow globally:
- Perform comprehensive risk assessments
Evaluate every stage of your product’s supply chain. Consider potential allergen exposure during raw material handling, storage, production, and distribution. Check with ingredient suppliers regularly as ingredient sources or specifications may change.
- Be transparent and specific
Advisory statements should be clear and truthful. For example, instead of noting “May contain nuts,” specify the type of nuts (e.g., “May contain peanuts and tree nuts”) to give consumers the information they need to make safe choices.
- Stay current with regional laws
Regulations governing PAL vary. For instance, recent consultations in the UK have pushed for stricter clarity and standardization of “May contain” wording. Monitor changes to the rules in every market you serve.
- Label when necessary, not excessively
If there is no risk of cross-contact, PAL shouldn’t be added. Highlight only the standard allergens that form part of a product’s ingredients as required by regional legislation, such as the FDA’s Food Allergen Labeling and Consumer Protection Act (FALCPA) in the US.
- Streamline compliance with TraceGains NutriCalc
Managing allergen labeling for multiple regions is no small task, but TraceGains NutriCalc nutrition calculation software can make it simpler. It’s a trusted tool for food manufacturers around the world, guiding you through allergen management and helping you create compliant ingredient declarations.
With TraceGains NutriCalc, you can:
- Highlight standard allergens in ingredient lists according to regional requirements.
- Create clear, customized “May contain” statements when necessary.
- Incorporate thorough ingredient allergen checks into your processes.
For end-to-end solutions, NutriCalc is available as part of the TraceGains networked product development suite. The suite helps you manage global regulatory needs, supplier and ingredient specifications, and every aspect of your product’s development lifecycle. It’s also available as a standalone product solution.
Protect consumers. Protect your brand.
Precautionary allergen labeling is meant to safeguard consumers, but when it’s overused or misapplied, it can create confusion, erode trust, and even increase liability. The good news? A smarter, more consistent approach is within reach.
See how TraceGains NutriCalc can help you get allergen labeling right. Request a demo to explore how automated calculations, defensible claims, and built-in regulatory support can make compliance second nature—no guesswork required.
