Which allergens do I legally have to control?

In the U.S., the FDA currently recognizes nine major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame), and they must be declared on labels. Sesame became the ninth major allergen on January 1, 2023.In the EU, food businesses must clearly identify 14 allergens, including celery, mustard, lupin, and sesame, in addition to milk, peanuts, soy, gluten cereals, and tree nuts. Your testing and sanitation program should reflect both the markets where you sell and your on-site cross-contact risks.

What’s the difference between lateral flow, ELISA, and PCR for allergen testing?

Lateral flow (like AlerTox® Sticks or AllerFlow Gluten) gives rapid yes/no style results on-site with no lab equipment, often in under 10 minutes. ELISA quantifies allergen proteins in parts per million (ppm) to document the amount of allergen present. PCR (foodproof® kits) detects allergen DNA with extremely high sensitivity (down to 0.1–1 ppm in complex foods) and supports challenging matrices such as spices, chocolate, and cooked meats.

How fast can I release an allergen-sensitive product?

Line operators can swab and run lateral flow tests at changeover to confirm the line is clean before starting an allergen-free SKU. ELISA or PCR can then quantify residual allergen in the finished product, typically in under ~2 hours, for documented release.

Do I need a specialized lab team to run these tests?

No. Lateral flow kits like AlerTox® Sticks are intentionally designed so production staff can run them with minimal training and no extra lab hardware. For ELISA and PCR, Hygiena provides ready-to-use kits, plate readers, cyclers, and sample preparation workflows, along with training and documentation, to bring testing in-house.

How do I prove compliance to auditors and customers?

Store and link each batch’s allergen test data, including the method (lateral flow / ELISA / PCR), detection limit (ppm), matrix, and result, to your lot/batch record. AOAC-validated methods and internal controls in PCR kits make that data defensible.

Bezpieczeństwo żywności

Wykrywanie alergenów

Bezpieczeństwo żywności ma kluczowe znaczenie w dzisiejszym krajobrazie, zwłaszcza w odniesieniu do potencjalnych alergenów. Nowoczesne technologie, takie jak PCR w czasie rzeczywistym, ELISA i testy przepływu bocznego, odgrywają kluczową rolę w identyfikacji i kwantyfikacji alergenów w żywności, zapewniając w ten sposób najwyższe standardy bezpieczeństwa i jakości dla konsumentów na całym świecie.

Why Food Manufacturers Rely on Allergen Detection and Control

Undeclared allergens can trigger severe reactions in consumers and drive costly recalls. Regulations now require clear labeling of major allergens - in the U.S., the FDA defines nine major food allergens, including sesame, and in the EU, food businesses must declare 14 allergens, including celery, mustard, lupin and others (FDA).

Reliable in-house allergen testing enables you to release products faster, verify sanitation steps, and defend ‘free-from’ and ‘may contain’ claims with data.

Protect consumers: Reduce risk of severe allergic reactions.
Avoid recalls: Catch residue before it leaves the plant.
Prove label claims: Document ‘dairy-free,’ ‘gluten-free,’ ‘sesame-free,’ etc.
Satisfy auditors: Demonstrate validated cleaning and changeover controls.
Speed up release: Get actionable results in minutes (lateral flow), under 2 hours (PCR/ELISA). Hygiena’s lateral flow AlerTox® Sticks are designed for line-side checks with no lab equipment, and PCR/ELISA kits deliver highly sensitive quantitative results.

How Hygiena Supports Allergen Risk Management From Raw Materials to Final Pack

Hygiena® Comprehensive Allergen Diagnostics and Data Management

Allergen risk isn’t just in the finished product. It can come from incoming ingredients, shared lines, tools, air/dust, employees, or rework. Hygiena’s workflow gives you checkpoints from pre-op through final label sign-off.

Testing can be surface-based (to verify sanitation), in-process (during changeovers), or product-based (to quantify allergen content before release or to defend ‘free-from’ claims). Hygiena offers tools for each step: rapid swab & lateral flow tests, quantitative ELISA, and high-sensitivity real-time PCR.

Incoming ingredients: Verify supplier claims (e.g., peanut-free, gluten-free) using real-time PCR or ELISA kits that can detect down to low ppm levels, often within ~100 minutes.
Equipment & surfaces: After cleaning, swab and run a lateral flow device (like AllerFlow Gluten) to confirm the line is allergen-free in ~10 minutes, no lab required.
In-process changeovers: Use AlerTox® Sticks right on the floor during product switches (e.g., peanut → non-peanut SKU). Kits are designed to be run by production staff, not just lab techs.
Final product & label claim: Quantify allergen content with ELISA or PCR and keep digital records for auditors and regulators. Hygiena’s foodproof® qPCR kits can detect allergens like gluten, peanut, hazelnut, soy, celery, etc., often at levels at low as 0.1–1 ppm in complex matrices such as spices, ice cream, chocolate, and meat products.

End-to-End Allergen Testing Solutions

Rapid Line-Side Screening (Lateral Flow & Swab Tests)

Get a quick yes/no before you start the next run.

Minutes to result; minimal training
Works on surfaces, rinse water, and raw/finished goods
Clear visual readout for pass/fail decisions
Great for verifying cleaning between allergen/non-allergen SKUs

Learn more about Lateral Flow

Quantification for Documentation (ELISA)

When you need numbers, not just a yes/no.

Numeric, traceable results (ppm) for reports
Validates sanitation and supplier claims
Handles a wide range of food matrices
Runs on standard plate readers with controls and curves

Learn more about ELISA

High-Sensitivity Confirmation & Complex Matrices (Real-Time PCR)

For tough products and trace levels.

Detects very low allergen traces in complex foods
Built-in controls increase confidence in results
Complements screening/ELISA for borderline cases
Compatible with common real-time PCR cyclers

Learn more about Real-Time PCR

Overview Allergen Testing Solutions by Target Allergen

Browse detection solutions for specific allergens. Each page shows available rapid tests (lateral flow), quantification kits (ELISA), and high-sensitivity PCR assays, along with matrices, detection limits, and validation resources.

Allergen	Typical Sources / Risk Areas	Detection Methods Available	Example Product	Region(s) Where It’s Legally Declared
Peanut	Nut butters, sauces, confections	Lateral Flow, ELISA, PCR	AlerTox® Sticks: Peanut; foodproof® Peanut Detection Kit	US “Big 9”, EU 14 (Peanuts)
Gluten	Wheat, barley, rye, oats, shared lines	Lateral Flow (AllerFlow Gluten), ELISA, PCR	AllerFlow Gluten; GlutenTox® ELISA Rapid G12	EU 14 (Gluten cereals), US (wheat)
Milk / Dairy	Dairy, chocolate, bakery fillings	Lateral Flow, ELISA	AlerTox® Total Milk Sticks	US “Big 9” (Milk), EU 14 (Milk incl. lactose)
Soy / Soya	Lecithin, sauces, protein isolates	Lateral Flow, ELISA, PCR	AlerTox® ELISA Soy; foodproof® Soya Detection Kit	US “Big 9” (Soybeans), EU 14 (Soybeans)
Sesame	Baked goods, tahini, spice blends	Lateral Flow (AlerTox® Sticks: Sesame)	AlerTox® Sticks: Sesame	Sesame is now legally the 9th major U.S. allergen and must be declared on labels.
Hazelnut / Tree Nuts	Chocolate, spreads, fillings, inclusions	Lateral Flow, ELISA, PCR	AlerTox® ELISA Hazelnut; foodproof® Hazelnut Detection Kit	US “tree nuts,” EU 14 (“Nuts”)
Celery / Mustard / Lupin, etc.	Spice blends, sauces, RTE savory foods	PCR (foodproof®), ELISA	foodproof® Celery Detection Kit	EU 14 requires declaration of celery, mustard, lupin, etc.

Why Hygiena for Allergen Control?

✓ Faster changeovers: Surface validation in minutes so production doesn’t stall between allergen / non-allergen runs.
✓ Documented proof for audits: Quantitative ELISA and PCR reports support regulatory inspections and customer requirements.
✓ Ultra-low detection limits: PCR down to 0.1–1 ppm in tough matrices like spices, chocolate, ice cream, cooked meats.
✓ Validated methods: AOAC PTM approvals and internal controls increase confidence in results.
✓ No specialized lab needed: Lateral flow sticks can be run by production staff — no pipettes or thermal cyclers required.
✓ Global compliance support: Supports U.S. “Big 9” allergens (including sesame, now mandatory to declare) and EU’s list of 14 required allergens.

Alergeny

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