Food Allergen Testing
& Gluten-Free Analysis

Protect your consumers and verify your labels. We provide quantitative food allergen testing and ELISA analysis for the "Big 9" allergens, gluten-free verification, and environmental cleaning validation.

Regulations
FALCPA & FASTER Act
Methodology
Quantitative ELISA
Certification
Gluten-Free <20 ppm

Prevent Recalls & Protect Consumers

Undeclared allergens are the #1 cause of food recalls in the United States. Under the FASTER Act of 2021, manufacturers must now label nine major allergens, including the newly added Sesame.
AGT Food Labs helps you verify your "Free From" claims. Whether you need to confirm a gluten-free production run or validate your cleaning procedures to prevent cross-contact, our high-sensitivity food allergen testing provides the scientific proof you need.

The Food Allergen Testing Workflow

We use the Enzyme-Linked Immunosorbent Assay (ELISA) method for precise protein detection.

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01. Submission
Send 100g of finished product or environmental swabs. Ensure samples are double-bagged to prevent cross-contamination.
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02. Extraction
We extract the specific allergenic proteins (not DNA) from the food matrix using validated buffers.
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03. ELISA Analysis
Target proteins bind to specific antibodies, creating a color change proportional to the allergen concentration.
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04. Validation Report
Receive a quantitative report (in ppm) confirming if your product meets FDA thresholds for labeling.

Our Food Allergen Testing Services

Comprehensive screening for ingredients, finished products, and manufacturing surfaces.

advanced food allergen testing. Include labeled test samples or vials representing the “Big 9” allergens
FASTER Act Compliance

The "Big 9" Allergen Screen

We test for all major allergens mandated by US law. Our flagship food allergen testing service provides quantitative data to help with risk assessment (VITAL 3.0), going beyond just a "Pass/Fail." We are also experts in navigating the FDA's specific definition of Tree Nuts, which includes Coconut—a common compliance trap for manufacturers.

We Test For:
  • Peanuts & Tree Nuts (Almond, Walnut, Cashew, Pecan)
  • Milk (Casein & Beta-Lactoglobulin)
  • Egg (Ovalbumin)
  • Soy, Wheat, Fish, Crustacean
  • Sesame (Newest FDA Requirement)
analyzing samples for gluten using advanced equipment. On the bench are labeled food samples
FDA <20 ppm

Gluten-Free Certification Testing

To label a product "Gluten-Free," the FDA requires it to contain less than 20 parts per million (ppm) of gluten. As part of our food allergen testing portfolio, we use the R5 Mendez Method (AOAC approved) to detect gluten from wheat, rye, and barley with a detection limit of 5 ppm, ensuring you are well within the safe zone.

Advanced Hydrolyzed Testing: Standard tests often fail on fermented products like Beer, Soy Sauce, or Sourdough. We utilize specialized Competitive ELISA which can detect broken-down gluten peptide fragments that standard Sandwich ELISA misses.

showing environmental allergen swabs being used to sample equipment surfaces like mixers, conveyor belts, and fillers. Include small labeled containers
Cleaning Validation

Environmental Allergen Swabs

Preventing "Cross-Contact" is the heart of any Food Safety Plan. If you run allergenic (e.g., Peanut) and non-allergenic lines in the same facility, you must Validate that your cleaning actually works.

We provide specific environmental food allergen testing kits for you to sample equipment surfaces (mixers, belts, fillers). We analyze these swabs to prove that your "Clean-in-Place" (CIP) procedures effectively remove proteins down to the microgram level, satisfying FSMA Preventive Controls requirements.

Detection Limits (LOQ)

We use high-sensitivity ELISA kits to detect trace levels of allergenic proteins.

Allergen Method Limit of Quantitation (LOQ)
Gluten (Gliadin)R5 Mendez ELISA5.0 ppm
PeanutELISA2.5 ppm
Milk (Total)ELISA2.5 ppm
EggELISA2.5 ppm
SoyELISA2.5 ppm
Almond / WalnutELISA2.5 ppm
SesameELISA5.0 ppm
SulfitesMonier-Williams10.0 ppm

Regulatory Compliance

Meeting the strict labeling laws of the United States.

FALCPA & FASTER Act

Our testing covers all 9 major allergens defined by the Food Allergen Labeling and Consumer Protection Act and the FASTER Act (Sesame).

FDA Gluten-Free Rule

We verify compliance with 21 CFR 101.91, ensuring your product tests below the mandatory 20 ppm threshold for gluten-free claims.

FSMA Preventive Controls

Our environmental swabbing program validates your Allergen Control Plan, a key requirement for FSMA audits.

Frequently Asked Questions

Common questions about allergen thresholds and testing methods.

What are the "Big 9" Allergens?
The FDA mandates labeling for: 1. Milk, 2. Eggs, 3. Fish, 4. Crustacean Shellfish, 5. Tree Nuts, 6. Peanuts, 7. Wheat, 8. Soy, and 9. Sesame (added in 2023).
Is Coconut considered a Tree Nut by the FDA?
Yes. Even though Coconut is botanically a fruit, the FDA classifies it as a Tree Nut for labeling purposes. Therefore, it must be declared on food labels, and we include it in our Tree Nut screens upon request.
Does a "May Contain" label protect me from testing?
Not entirely. "May Contain" (Precautionary Allergen Labeling) is voluntary and does not exempt you from Good Manufacturing Practices (GMP). You still have a legal duty to prevent cross-contact. Testing validates that your controls are working, regardless of the label.
Why use ELISA instead of PCR?
Allergic reactions are caused by **Proteins**, not DNA. ELISA detects the actual protein that causes the reaction. PCR detects DNA, which might be present even if the protein is gone, or absent if the DNA was destroyed by heat (cooking). Therefore, ELISA is the gold standard for finished food safety.
Is a product with 15 ppm Gluten safe?
Yes, according to the FDA. The legal limit for "Gluten-Free" labeling is **<20 ppm**. While some certification bodies suggest lower limits (e.g., 10 ppm), 15 ppm is legally compliant for a Gluten-Free label in the US.
Do you test for Sulfites?
Yes. While not a "Big 9" allergen, Sulfites must be declared on the label if they exceed **10 ppm**. We use the optimized Monier-Williams method for accurate sulfite detection in wine, dried fruit, and seafood.

Verify Your "Free From" Claims.

Ensure your products are safe for allergic consumers with our accredited food allergen testing services.

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