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On September 26, 2023, US FDA issued an updated Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This new guidance material includes a new chapter specific to allergens. Key take-aways include:
  1. Establish and Implement a Food Allergen Program. The guidance document explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens.
  2. Allergen Controls. The guidance provides many examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using CGMPs and preventive controls.
  3. Label Controls. Labeling errors are the cause of most FDA food allergen recalls. This guidance includes information on how to monitor or verify that the food allergens are properly declared as required and the correct label is used for the product.
  4. Training. Successful control of food allergens depends on the involvement of all personnel in all phases of product development, ingredient procurement/sourcing, receiving, production and distribution of foods. The guidance document details some examples of training topics, based on an employee’s position and responsibilities.
Personnel Functions Training Topics
Purchasing Awareness that food allergen hazards may require supply-chain controls with associated supplier approval and verification activities
Receiving Procedures for receipt, handling, and storage of allergen-containing raw materials and other ingredients to ensure that they are appropriately identified and stored
Production operations The food allergen control measures employed during production, including the preventive measures, corrective actions, and records applicable to each employee’s position
Management of WIP and rework  Awareness of the importance of controlling WIP and rework to prevent allergen cross-contact
Maintenance Measures to prevent allergen cross-contact (e.g., through maintenance tools) between production lines
Cleaning operations Awareness of the key role of cleaning procedures in preventing allergen cross-contact
Supervision The plant’s food allergen program applicable to the supervisory responsibilities
EAS Consulting Group will closely monitor these as well as other FDA and USDA updates throughout 2023 and beyond, communicating these expectations to our clients as available.

In the meantime, a thorough review of your allergen management and control programs may be warranted so that you will be able to quickly understand the current FDA thinking and pivot to meet these new expectations.   If you have questions regarding this new guidance material or would like assistance in conducting an Allergen Gap Assessment, please contact EAS Consulting Group.

We invite you to visit our website to learn more about our US FDA regulatory capabilities and to contact us if we can be of assistance.

Posted in FDA and USDA Regulatory Update, Uncategorized.