Food allergen labeling is an important part of creating a compliant food label. When a formula contains an ingredient that is or contains a major food allergen, the applicable allergen must be properly identified on the finished product label. FDA’s allergen labeling requirements apply to FDA-regulated packaged foods, including dietary supplements. (FDA: Food Allergies)

Managing this information can become more complicated as a product contains more ingredients or a manufacturer manages a larger ingredient library. Panelgea® allows users to specify applicable allergens at the ingredient level so that allergen information can remain associated with the ingredient as it is used in product formulations.

Rather than attempting to automatically determine whether an ingredient contains an allergen, Panelgea relies on the allergen information established by the user.

What Are the Nine Major Food Allergens?

Federal law currently recognizes nine major food allergens:

• Milk
• Egg
• Fish
• Crustacean shellfish
• Tree nuts
• Peanuts
• Wheat
• Soybeans
• Sesame

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) established requirements addressing eight major food allergens. The FASTER Act subsequently added sesame as the ninth major food allergen, with the sesame labeling requirement becoming effective January 1, 2023. (FDA: Food Allergies)

These requirements extend beyond conventional foods. FDA explains that packaged foods regulated under the Federal Food, Drug, and Cosmetic Act, including dietary supplements, are subject to applicable major food allergen labeling requirements.

Why Should Allergen Information Be Managed at the Ingredient Level?

A finished product’s allergen information ultimately depends on the ingredients used to make it. Keeping allergen information associated with the underlying ingredient creates a structured way to manage that information during formulation.

For example, when creating an ingredient in Panelgea, a user can specify the applicable allergen information for that ingredient. When that ingredient is later selected for a formulation, its established information remains connected to the ingredient record.

This creates a more structured relationship between:

Ingredient Record → User-Specified Allergen Information → Product Formula

For manufacturers working with recurring ingredients across multiple products, this can reduce the need to repeatedly establish the same ingredient information every time a new product is formulated.

How Does Allergen Management Work in Panelgea?

Panelgea allows users to establish applicable allergen information when managing their ingredient records. The system does not independently determine that an ingredient contains an allergen simply based on its ingredient name.

Instead, the user is responsible for reviewing the ingredient and its supporting information and specifying the appropriate allergens within the ingredient record.

The workflow can be summarized as:

Create or Review Ingredient → Specify Applicable Allergens → Use Ingredient in Formula → Review Product Information → Generate Panel

This distinction is important because automated software should not be expected to determine information that has not been provided or established by the user.

Where Should Ingredient Allergen Information Come From?

Allergen information should be established using reliable information about the ingredient rather than assumptions based solely on its name.

Depending on the ingredient, relevant information may come from supplier specifications, allergen statements, ingredient composition documentation, manufacturing information, or other appropriate supplier and regulatory documentation.

This is particularly important for ingredients whose source may not be immediately apparent from the ingredient name. FDA identifies ingredients such as casein, sodium caseinate, and whey as milk proteins, illustrating why reviewing the underlying ingredient information can be important when determining allergen status. (FDA: Food Allergies)

Panelgea provides a place to maintain the applicable allergen information, while the user remains responsible for establishing that information accurately.

Why Is Reusable Allergen Information Useful?

Manufacturers frequently use the same ingredient across multiple formulations. If allergen information is maintained only at the finished-product level, the same determination may need to be made repeatedly.

Associating the information with the ingredient itself creates a reusable ingredient record. When the ingredient is used again, its established information remains available as part of that record.

This approach can be particularly useful for manufacturers maintaining larger ingredient libraries or developing multiple products that share common raw materials.

How Must Major Food Allergens Be Declared?

FDA requires the food source of a major food allergen to be identified on the label when applicable. Depending on the ingredient and labeling approach, the allergen source may be identified within the ingredient statement or through a separate Contains statement immediately after or adjacent to the ingredient list. (FDA: Food Allergies)

Certain allergens require additional specificity. For example, applicable labeling requirements address identification of the particular species of fish or Crustacean shellfish and the specific type of tree nut.

This means allergen management involves more than simply recording that a product contains one of nine allergen categories. The underlying ingredient information and applicable labeling requirements still need to be reviewed.

What Changed When Sesame Became a Major Food Allergen?

The FASTER Act designated sesame as the ninth major food allergen. The labeling requirement became effective on January 1, 2023, bringing sesame within the federal major food allergen labeling framework. (FDA: The FASTER Act and Sesame)

For ingredient management, this means sesame should be considered when establishing the applicable allergen information associated with an ingredient.

Maintaining allergen information within structured ingredient records also provides a more organized way to manage the information as regulatory requirements evolve.

Does Allergen Management Replace Supplier Documentation?

No. Panelgea provides functionality for recording and managing allergen information, but that information is only as accurate as the information entered by the user.

Supplier documentation may therefore remain an important part of determining whether an ingredient contains or is derived from a major food allergen. The appropriate documentation will depend on the ingredient, supplier, manufacturing circumstances, and other relevant factors.

Panelgea should be viewed as a tool for managing established ingredient information, rather than as a substitute for supplier documentation or regulatory review.

What About Allergen Cross-Contact?

Ingredient allergen information and allergen cross-contact are separate considerations.

An ingredient record can identify allergens known to be associated with that ingredient. It cannot, by itself, determine whether a finished product could be exposed to an allergen through manufacturing conditions such as shared equipment, production lines, facilities, sanitation practices, or supplier operations.

FDA separately addresses controls intended to prevent allergen cross-contact during food manufacturing. (FDA: Food Allergies)

Manufacturing and supplier information should therefore be evaluated independently where cross-contact may be relevant.

Allergen Information Should Be Part of Ingredient Management

Nutrition labeling begins with accurate product information. Nutritional values, ingredient classifications, formulation amounts, serving information, and allergen information can all affect the finished label.

Panelgea brings this information into a structured ingredient and formulation workflow. Users can create and maintain ingredient records, specify applicable allergen information, formulate products, review the product information, and generate the appropriate facts panel.

When an ingredient is reused in another formulation, its established information remains part of the ingredient record rather than having to be recreated from scratch.

Allergen Management Is Only One Part of Label Compliance

Correct allergen information does not independently make an entire food label compliant. Nutrition labeling may also involve serving information, nutrient declarations, FDA rounding requirements, ingredient declarations, panel formatting, claims, and other applicable requirements.

Panelgea combines ingredient management with nutritional calculations, compliance checks, multiple panel formats, and facts-panel generation to support the broader labeling workflow.

Final compliance depends on the accuracy and completeness of the product, ingredient, formulation, nutritional, serving, allergen, and other applicable information supplied by the user.

What Should Nutrition Labeling Software Provide for Allergen Management?

When evaluating nutrition labeling software, manufacturers should look beyond whether there is simply an allergen field. The more useful question is how that information is connected to the underlying ingredient data and formulation workflow.

For Panelgea, allergen information is established as part of the ingredient record. That allows users to maintain the information alongside other ingredient data and use those records when developing products.

The software helps organize and carry forward the information the user establishes. It does not replace the user’s responsibility to determine the correct allergen status of an ingredient.

Manage Ingredient and Allergen Information With Panelgea

Panelgea brings ingredient management, nutritional calculations, allergen information, compliance checks, FDA rounding, and facts-panel generation into a single workflow for food, beverage, and dietary supplement products.

Users can maintain ingredient records, specify applicable allergen information, formulate products, review product information, and generate packaging-ready facts panels in JPG, PNG, PDF, and SVG formats.

By maintaining allergen information at the ingredient level, Panelgea provides a structured way to carry established allergen information through the product formulation and labeling workflow without representing the software as independently detecting an ingredient’s allergen status.