Tip of the Week: A Closer Look at Allergen Cross-Contact – One GMP Provision at a Time

July’s Tip of the Week series will uncover FSMA’s revised GMPs and how they focus on food allergen cross-contact. FSMA’s Hazard Analysis and Risk Preventive Controls (HARPC) rule recently revised several provisions – 24 to be exact – of the cGMP, Part 110, to address and control potential allergen cross-contact as part of the preventive controls. These new requirements are contained in Part 117 - Current Good Manufacturing Practices, Hazard Analysis and Risk Prevention Controls.

Throughout July, our Tip series will uncover the area of focus, the section number and clarification of reasoning, action requirements, and ways you can apply them for each of the 24 allergen cross-contact provisions.

This week’s Tip focuses on preventing allergen cross-contact with proper handling of raw materials, ingredients, process controls, and operations. It is advisable to read and think about the reasoning provided by the FDA to justify including allergen cross-contact prevention in the updated GMPs. 

Processes and controls—raw materials and ingredients, § 110.80(a)(5)

Clarification. Improper handling of raw materials and ingredients may result in the transfer of food allergens to food

Proposed § 117.80(b)(5)

Would require that raw materials, ingredients, and rework be held in bulk, or in containers designed and constructed so as to protect against cross-contact and contamination and must be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such.

Example:  Dedicated and properly labeled containers for each individual allergen is a must. Cross contact in bulk handling systems can be a real problem because it is not obvious that contamination has taken place. It is important to have clear and concise procedures for receiving and transferring raw materials or rework into bins, scaling systems, and containers so that different allergens are not put in the wrong bin or container. Other potential issues are the design and condition of the bulk equipment which could allow for excessive dust or catch areas in the equipment that allow for a static buildup of different allergens in a system that is essentially supposed to be self-cleaning. If your raw materials are hygroscopic (i.e. low moisture) they would likely absorb moisture in warm and humid conditions that would allow for scale buildup (difficult cleaning) or a higher water activity that could allow for harmful bacteria growth. It is essential to inspect your bulk systems, containers, and rework usage to ensure that cross-contact is not occurring.

Processes and controls—raw materials and ingredients, § 110.80(a)(7)

Clarification. Improper handling of raw materials and ingredients may result in the transfer of food allergens to food.

Proposed § 117.80(b)(7)

Would require that liquid or dry raw materials and ingredients received and stored in bulk form be held in a manner that protects against cross-contact and contamination.

Clarification: Cross-contact may be associated with improper identification and holding of raw materials and ingredients that are food allergens, and rework that contains food allergens. Improper identification of an allergen-containing raw material, such as a seasoning mix that is not identified as containing soy protein, can result in the unintended incorporation of an allergen into a food (i.e., cross-contact). Improper holding, for example storing open containers of raw materials, including those containing allergens, in the same location can result in cross-contact.

Proposed § 117.80(b)(8)

Would require that raw materials and ingredients that are food allergens, and rework that contains food allergens, be identified and held in a manner that prevents cross-contact.

Example: Allergen-containing raw materials, such as ingredient mixes, must be properly identified otherwise they can result in the unintended incorporation of an allergen into a food or improper holding. Review the packaging material ingredients list during receiving. Specification sheets should clearly identify when an allergen ingredient is contained. The sheet may have this information highlighted in a separate row or color-coded to match the allergen color-code used in the plant. Improper storing and handling of allergen-containing raw materials or ingredients, can result in cross-contact.

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