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FOOD ALLERGEN PREVENTIVE CONTROLS FOR HUMAN FOOD
Food Allergen Preventive Controls Objectives (cont’d) (Slide 10-‐1 a)
• Include only allergen preventive controls that are identified in the hazard analysis requiring a preventive control
• If different food allergens are handled at the same time § Allergen cross-‐contact may be the prevention
• If food allergens are in a product § Allergen labeling may be the prevention
When is an Allergen Control a Preventive Control? (Slide 10-‐2 a)
• Some facilities use icons to identify ingredients containing food allergens. This can usually be managed as a GMP rather than a preventive control. Focus resources on what matters most.
• The term “sanitation” may include both cleaning and sanitizing activities. § Cleaning is necessary to control allergens. § Sanitizing is intended to kill microorganisms. Sanitizing has little or no impact on allergens.
Tree Nuts [Section 201 (qq)] – may be revised (Slide 10-‐3 a)
CommonCOMMON/USUAL NAME (used for declaration of specific type of nut)
Almond Chestnut (Chinese, American, European, Seguin)
Hickory nut Pili nut
Beech nut Chinquapin Lichee nut Pistachio
Brazil nut Coconut Macadamia nut/ Bush nut
Butternut Filbert/hazelnut Pecan Walnut (English, Persian, Black, Japanese, California), Heartnut, Butternut
Cashew Ginko nut Pine nut/Pinon nut
Source: http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm238807.htm (accessed November 17, 2017)
Other Countries (Slide 10-‐3 b)
• Canada http://www.inspection.gc.ca/food/information-‐for-‐ consumers/fact-‐sheets/food-‐ allergies/eng/1332442914456/1332442980290 accessed November 17, 2017
ALLERGEN ALLERGEN Eggs Soy Milk Wheat Peanuts Mustard Tree nuts Sesame Seafood (Fish, crustaceans, shellfish)
Sulphites (>10 ppm): not a true allergen
Other Countries (cont’d) (Slide 10—3 c) • Europe http://www.eufic.org/article/en/expid/EUFIC_Review_ on_Food_Allergens/ accessed November 18, 2017
ALLERGEN ALLERGEN Eggs Molluscn shellfish
Milk and products Cereals containing gluten
Nuts (almonds, hazelnut, walnut, cashew, pecan, brazil nut, pistachio, macadamia, Queensland nuts)
Sulphur dioxide and sulphites (>10 ppm): not a true allergen
Fish Sesame seeds
Other Countries (cont’d) (Slide 10-‐3 d) • Others
Country ALLERGEN Australia Molluscan shellfish Japan Buckwheat Others Barley, rye
Allergen Preventive Controls Requirements (cont’d) (Slide 10-‐4 a)
• For accurate allergen labeling of finished food, also be aware of § Formulation mistakes § Ingredient substitution § Supplier producing several allergen containing ingredients § Undeclared allergens as a major cause of food recalls.
• Need supply-‐chain program for a supplier that produces several allergen containing ingredients, such as nuts.
June 20, 2017 JFC International Inc. issues missing English label resulting in no allergy alert because of undeclared wheat, soybean, and fish (Bonito) in Futaba Sesame Hijiki Rice Seasoning. No illnesses have been reported.
June 20, 2017 United Natural Foods, Inc. (UNFI) issues a recall of a single production batch of Fat Cat Purry-‐Purry Sauce Hot Sauce because an ingredient supplier, Woodland Foods of Chicago, IL, notified Fat Cat Gourmet Foods that there was a possible peanut contamination in the peri-‐peri peppers used. No illnesses have been reported.
Source: https://www.fda.gov/Safety/Recalls/ucm563889.htm (accessed July 3, 2017)
Allergen Cross-‐contact Prevention Considerations (cont’d) (Slide 10-‐5 a)
Prevent cross-‐contact by: • Not processing different food allergens at the same time or at
all • Not having conflicting schedules with other operations • Managing allergens as a prerequisite program or a preventive
control • Keeping track of allergens from receiving to finished product • Training employees to make them understand the seriousness
How the facility manages their system and the complexity of their allergen concerns will determine if above are PC or prerequisite program. All of the above must be documented.
Equipment Cleaning (cont’d) (Slide 10-‐6 a) A Potential Preventive Control for Allergens
• In the absence of established allergen thresholds, thorough cleaning means no visible residue at a minimum (visually clean).
• Validation of allergen cleaning procedures may be useful, desirable, or strongly encouraged: § If cleaning procedures need to be adjusted § The first time a unique allergen is introduced for a complex equipment on a production line
§ When major changes are made to product formulation.
Equipment Cleaning (cont’d) (Slide 10-‐6 b) A Potential Preventive Control for Allergens
• Validation results are recorded in Sanitation Record or Allergen Scheduling Record
• Validation helps to protect your business and the consumer’s health
• Ways alternative to equipment cleaning § Color-‐coding or labeling equipment—see handouts in my website
§ Using physical barrier (walls, curtains, partitions) between production lines in close proximity
§ Training of staff
Verification of Allergen Cleaning (cont’d) (Slide 10-‐7 a)
• No need to validate visually clean if met • During changeovers, “Push Through” material may be
used to establish safe times and volumes • Adenosine triphosphate (ATP) tests and protein swabs
may not detect low levels of allergens that cause allergenic reactions but indicate effectiveness or extent of cleaning. ATP is the molecule that most cells use as their main energy.
• Enzyme-‐linked ImmunoSorbant Assays (ELISA) and Polymerase Chain Reaction (PCR) are more sensitive and can detect food allergens at the molecular level levels.
• Testing of all allergens is now possible.
Examples of Test Kits (not an endorsement) (Slide 10-‐7 b)
• Neogen: Almond, β-‐Lactoglobulin (BLG), casein, cashew, crustacean, egg, gliadin/glute