How to establish a written allergen control program

Used in conjunction with the Allergy Guidance resource, this checklist will assist you in establishing and implementing a written allergen control program as required by the California Code of Regulations, title 4 (4 CCR) section 17214(d)(3), Product Quality Plan.

Each manufacturing premises and its operations are unique. Additional controls may be needed to ensure compliance with the regulations.

Following these steps will assist you to establish a written document that identifies the allergens in your facility, identifies the allergens in each of your cannabis products, and details the steps to take to mitigate against allergen cross-contact and the unintentional or undisclosed incorporation of a food allergen into a cannabis product and the unintentional ingestion of a food allergen by a consumer.

1. Identify and document the allergens present in your facility

• Review the ingredient lists and allergen warnings on your ingredients
  • Be aware of sub-ingredients and allergens that go by other names (see table in the Allergy Guidance resource)
• Document all identified allergens

2. Identify and document which of your cannabis products contain allergens

• Review product formulations and sub-ingredients
  • Allergens can be associated with certain flavors or product lines
  • Some products may contain more than one allergen
  • Document the identified cannabis products and their allergens

3. Ensure proper storage of allergens and allergen-containing components (e.g., ingredients)

[4 CCR §17212(b)(2), (b)(6) & (b)(8)]

• Label and identify components containing allergens
  • Properly store components containing allergens to prevent allergen cross-contact
  • Describe your component storage procedures in writing

4. Identify and implement production controls to mitigate allergen cross-contact

[4 CCR §17208(a)]

• When appropriate, use scheduling, cleaning and sanitizing protocols, and dedicated equipment and utensils to mitigate allergen cross-contact
• Describe your production controls in writing
• Incorporate your production controls into your master manufacturing protocols

5. Implement labeling controls

[4 CCR §17208(a), 4 CCR §17398(c)(3) and 4 CCR §17406(a)(5) & (a)(6)]

• Correctly label allergens in cannabis products and ensure accurate “contains” statements
• Label bulk cannabis products containing any allergens
• Describe your labeling controls in writing

6. Train staff

[4 CCR §17211.1 and 4 CCR §17211(a)(2)]

• Include an allergen control component in the staff training program
• Document trainings and repeat annually

Related content