Allergen Testing

Yes, the AgriStrip® test kits can be easily implemented into routine analysis as part of an allergen management plan within a HACCP-concept. The simple test format makes it easy for a smooth workflow both on-site and in the lab.

However, we recommend submitting your product to us for testing rather than conducting in-house testing. If you need to validate the absence of allergen post sanitation via rinse water or swab testing, you can do so in house.

Contact Romer Labs® to set up an account, order your test kits, obtain package inserts, or if you have any questions.

If you conduct your own testing, be sure to record your results.

The AgraStrip® Allergen lateral flow tests are for the detection of trace amounts of allergens in a low ppm range in the following samples:

• Raw materials
• Finished food samples
• Rinse water (as part of cleaning validation)
• Environmental swab samples (as part of cleaning validation)

If the sample contains more than 1% (10,000 ppm) allergen, the test will return a negative result.

Results are either positive or negative, with the threshold defined by the detection limit of each allergen type (click on each allergen to obtain the detection limit). The assay is not designed to quantify the amount of an allergen, but rather to validate the absence of a given allergen in a product sample or environmental swab.

The FDA specifies that any foods labeled as “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” must contain less than 20 parts per million (ppm) of gluten. This level is the lowest that can be reliably detected using scientifically validated analytical methods. Other countries and international bodies use the same criteria, as most people with celiac disease can tolerate foods with very small amounts of gluten.

Besides the limit of gluten to 20 ppm, the rule permits labeling a food “gluten-free if the food does not contain:

• An ingredient that is any type of 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 results in the food containing more than 20 ppm of gluten.

Please learn more about FDA requirements for “gluten-free” claims and Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.

The Voluntary Incidental Trace Allergen Labelling (VITAL®) Program has been developed to provide a risk-based methodology for food manufacturers to assess the impact of allergen cross-contact and provide appropriate precautionary allergen labelling (PAL). Application of this approach aims to avoid the indiscriminate use of PAL, preserving its value as a risk management tool while effectively communicating risks to allergic consumers.

Sources:

Allergen Bureau. (2019). Summary of the 2019 VITAL Scientific Expert Panel recommendations. 

Allergen Bureau. (2023). The food industry guide to the Voluntary Incidental Trace Allergen Labelling (VITAL®) program (Version 3.1). 

The preferred method to identify and quantify cross-contact allergens in a VITAL ® risk assessment is to sum the cross-contact which is identified by the supplier in each raw material with cross-contact allergens identified during a physical audit of the production environment.

However, allergen analysis also plays a significant role in:

• Validating the VITAL® risk assessment;
• Verifying ingredient allergen statements and potential raw material cross-contact;
• Targeted analysis of problem pieces of processing equipment;
  confirming assumptions made during the implementation of VITAL® (e.g., validation of cleaning);
• Testing the allergen status of the final product to compare with calculated results from the VITAL® assessment (this may be especially relevant to high risk environments);
• Monitoring the effect of critical changes.

Sources:

Allergen Bureau. (2019). Summary of the 2019 VITAL Scientific Expert Panel recommendations.

Allergen Bureau. (2023). The food industry guide to the Voluntary Incidental Trace Allergen Labelling (VITAL®) program (Version 3.1). 

Analysis is complex and thus needs to be matrix- and allergen-specific.

It is important to consider the nature of the food or surface under analysis and the processes to which it has been exposed to ensure that the method applied is appropriate.

When comparing analytical test results with concentrations calculated from a VITAL® risk assessment, it is important to ensure that the units of measurement are comparable.

The quantitative assessment of cross-contact allergens needs to take the sporadic nature of cross-contact allergens into account by applying a comprehensive testing regime.

Allergen analysis can be used to validate the assumptions in the allergen management plan as well as the results from physical assessments.

Sources:

Allergen Bureau. (2019). Summary of the 2019 VITAL Scientific Expert Panel recommendations.

Allergen Bureau. (2023). The food industry guide to the Voluntary Incidental Trace Allergen Labelling (VITAL®) program (Version 3.1). 

The VITAL® risk assessment should be reviewed when (but not limited to):

• Any assumptions of the previous VITAL® risk assessment are changed;
• Ingredients or suppliers are changed;
• Equipment or manufacturing processes are changed;
• Cleaning procedures are changed;
• Consumer complaints are received regarding allergic reactions
• OR Every 12 months, whichever occurs sooner.

Sources:

Allergen Bureau. (2019). Summary of the 2019 VITAL Scientific Expert Panel recommendations.

Allergen Bureau. (2023). The food industry guide to the Voluntary Incidental Trace Allergen Labelling (VITAL®) program (Version 3.1). 

For detailed guidance, please refer to this article.

Sources:

Allergen Bureau. (2019). Summary of the 2019 VITAL Scientific Expert Panel recommendations.

Allergen Bureau. (2023). The food industry guide to the Voluntary Incidental Trace Allergen Labelling (VITAL®) program (Version 3.1). 

• Sample should represent real-world product as received by the end customer and/or be homogeneous with the batch it represents.
• Packaging should maintain sample integrity by preventing exchange with the atmosphere.
• Ship next day or 2nd day, avoid Saturdays and weekends.
• If your product is normally refrigerated, pack with cold packs.
• Non-refrigerated products can be shipped without cold packs.
• Please do not use Dry Ice and do not freeze samples

Ship or deliver samples to:
Murray-Brown Laboratories, Inc
Attn: Sample Receiving
11455 Pearl St., Northglenn, CO. 80233

No, we only report to contacts you specify in your New Client Paperwork.