Food Allergen Testing
& Gluten-Free Verification

Protect your consumers and verify your "Free From" labels with quantitative food allergen testing for the FDA "Big 9" allergens, gluten verification, and environmental cleaning validation.

Allergens Covered

FDA Big 9 + Gluten + Sulfites

Method

Quantitative ELISA · R5 Mendez (gluten)

Reporting

In-house screening · PJLA-accredited reports via partner network

Turnaround

5–7 Business Days · Rush 48–72h

Prevent Recalls with Reliable Food Allergen Testing

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. Accurate compliance combines allergen verification with strong nutritional analysis and food labeling data on the final pack.

AGT Food Labs supports your "Free From" claims through validated commercial ELISA methods. Whether you need to confirm a gluten-free production run or validate your facility's food hygiene and cleaning procedures to prevent cross-contact, our food allergen testing program delivers actionable data for your Allergen Control Plan.

Scope note: Our PJLA ISO/IEC 17025:2017 accreditation (Cert L24-482-R2) does not currently include allergen ELISA methods. Allergen verification is offered as in-house non-accredited screening, with PJLA / ISO 17025 accredited reporting available through our partner laboratory network when required.

The Food Allergen Testing Workflow

Enzyme-Linked Immunosorbent Assay (ELISA) for precise allergenic protein detection.

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01. Submission

Send 100g of finished product or environmental swabs. Double-bag samples to prevent cross-contamination during transit.

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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, producing a color change proportional to the allergen concentration.

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04. Quantitative Report

Receive a quantitative report (in ppm) with full transparency on whether the result is in-house screening or partner-issued accredited data.

Request an Allergen Test

Our Food Allergen Testing Services

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

ELISA test plate for FDA Big 9 food allergen testing including Sesame

FASTER Act Compliance

The "Big 9" Allergen Screen

We screen for all major allergens mandated by US law using validated commercial ELISA kits. Quantitative data supports VITAL 3.0 risk assessment — moving you beyond simple "Pass/Fail" reasoning. We're also experts in the FDA's specific definition of Tree Nuts, which includes Coconut — a common compliance trap for manufacturers.

We Screen For:

Peanuts & Tree Nuts (Almond, Walnut, Cashew, Pecan)
Milk (Casein & Beta-Lactoglobulin)
Egg (Ovalbumin)
Soy, Wheat, Fish, Crustacean
Sesame (Newest FDA Requirement)

Gluten verification by R5 Mendez ELISA for FDA Gluten-Free claim

FDA <20 ppm

Gluten-Free Verification

To label a product "Gluten-Free," the FDA requires it to contain less than 20 parts per million (ppm) of gluten. Our food allergen testing program uses the R5 Mendez Method (AOAC-approved commercial kit) to detect gluten from wheat, rye, and barley with a typical detection limit of 5 ppm — well within the safe zone.

Hydrolyzed & Fermented Products: Standard sandwich ELISA can fail on fermented products like beer, soy sauce, or sourdough. We deploy specialized Competitive ELISA which detects broken-down gluten peptide fragments that standard sandwich kits miss.

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 sanitation actually works.

We provide environmental food allergen testing kits to sample equipment surfaces (mixers, conveyor belts, fillers). Swabs are analyzed to confirm that your "Clean-in-Place" (CIP) procedures effectively remove allergenic proteins down to the microgram level, supporting FSMA Preventive Controls expectations.

Detection Limits (LOQ)

Validated commercial ELISA kits with low-ppm sensitivity for trace allergenic proteins.

AGT Food Labs — Food Allergen Testing Detection Limits (in-house screening unless an accredited partner-network report is requested)
Allergen	Method	Limit of Quantitation (LOQ)
Gluten (Gliadin)	R5 Mendez ELISA	5.0 ppm
Peanut	Quantitative ELISA	2.5 ppm
Milk (Total)	Quantitative ELISA	2.5 ppm
Egg	Quantitative ELISA	2.5 ppm
Soy	Quantitative ELISA	2.5 ppm
Almond / Walnut	Quantitative ELISA	2.5 ppm
Sesame	Quantitative ELISA	5.0 ppm
Sulfites	Optimized Monier-Williams	10.0 ppm

All methods listed above are commercial validated kits run as in-house screening. Where buyers, regulators, or audits require a PJLA / ISO 17025 accredited Certificate of Analysis, results are issued through our accredited partner laboratory network.

Industries We Serve

Food allergen testing across every food and beverage vertical that carries an FDA "Free From" claim.

Bakery and cereal products gluten-free verification

Bakery & Cereals

Gluten and wheat verification for breads, fortified cereals, snack bars, and gluten-free bakery lines.

Snacks and confectionery allergen screening

Snacks & Confectionery

Peanut, tree nut, milk, and soy screening for chocolate, candy, granola bars, and savoury snacks where shared lines drive cross-contact risk.

Beverages

Gluten and milk-protein checks for craft beer, plant-based milks, RTD beverages, and protein shakes selling into "Free From" categories.

Dietary supplements and sports nutrition allergen verification

Dietary Supplements & Sports Nutrition

Soy, milk, peanut, and gluten verification for protein powders, capsules, and bars where allergen-free labelling is a core marketing claim.

Common Triggers for Food Allergen Testing

Most manufacturers commission food allergen testing when one of these business situations comes up.

🚀Pre-Launch Verification

A new SKU, recipe, or co-pack run is heading to market and you need a documented Big 9 baseline before printing labels and shipping.

🛒Retailer or Buyer Audit

A major retailer, food-service buyer, or private-label brand has requested third-party allergen verification as part of supplier qualification or annual surveillance.

🛡️FSMA Allergen Control Plan

Your written Food Safety Plan requires periodic verification of allergen-control preventive measures — environmental swabs and finished-product checks both feed this evidence file.

⚠️Recall or Complaint Investigation

A consumer reaction, retailer complaint, or undeclared-allergen alert needs a fast quantitative answer to size the issue and scope a corrective action.

🌱"Free From" Certification

Programs like Gluten-Free Certification Organization (GFCO), Vegan, or Kosher require ongoing allergen evidence for renewal cycles.

🧼Cleaning Validation

A new piece of shared equipment or a CIP procedure change needs validation that protein removal works down to the microgram level before resuming production.

Regulatory Compliance

Meeting the strict allergen labeling laws of the United States.

📋FALCPA & FASTER Act

Our food allergen testing program covers all 9 major allergens defined by the Food Allergen Labeling and Consumer Protection Act and the FASTER Act (which added Sesame in 2023).

🌾FDA Gluten-Free Rule

We verify compliance with 21 CFR 101.91, ensuring your product tests below the mandatory 20 ppm threshold required for "Gluten-Free" claims.

🛡️FSMA Preventive Controls

Our environmental swabbing program supports your written Allergen Control Plan, a key requirement for FSMA Preventive Controls audits.

Frequently Asked Questions

Common questions about allergen thresholds, testing methods, and accreditation scope.

Is AGT's food allergen testing PJLA-accredited?

Allergen ELISA methods are not currently included in our PJLA ISO/IEC 17025:2017 accreditation scope (Cert L24-482-R2). We perform allergen verification as in-house non-accredited screening using validated commercial ELISA kits. When you require a PJLA / ISO 17025 accredited Certificate of Analysis — for retailer audits, customs documentation, or regulatory submissions — we coordinate testing with our accredited partner laboratory network at no extra coordination fee.

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 under the FASTER Act).

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. It must be declared on food labels, and we include it in our Tree Nut screen on 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 can persist even after the protein has been denatured, or be destroyed by heat while protein remains. ELISA is the gold standard for finished-product food allergen testing.

Is a product with 15 ppm Gluten safe to label "Gluten-Free"?

Yes, according to the FDA. The legal limit for the "Gluten-Free" label claim is <20 ppm. While some certification bodies recommend stricter 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 as in-house screening for sulfite detection in wine, dried fruit, and seafood.

Verify Your "Free From" Claims.

Ensure your products are safe for allergic consumers with our quantitative food allergen testing program.

Request an Allergen Quote

Food Allergen Testing & Gluten-Free Verification