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Regulatory Compliance & Food Safety Flashcards

7 cards from real CPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Regulatory Compliance & Food Safety flashcards as text
  1. Under FDA 21 CFR Part 177, which category of materials is specifically regulated for use in food contact applications?

    Answer: Indirect food additives including polymers

    21 CFR Part 177 covers indirect food additives such as polymers used in food-contact packaging materials.

  2. What is the primary purpose of a migration study in food packaging compliance?

    Answer: To measure how much packaging material transfers into the food

    Migration studies quantify how much chemical substance moves from the packaging into the food or food simulant under defined conditions.

  3. Which FDA regulation governs Current Good Manufacturing Practice (cGMP) for manufacturing, packing, or holding human food?

    Answer: 21 CFR Part 117

    21 CFR Part 117 establishes cGMP and Hazard Analysis and Risk-Based Preventive Controls (HARPC) requirements for human food facilities.

  4. A packaging supplier provides a 'letter of compliance' stating their material meets FDA regulations. What additional action should a food manufacturer take?

    Answer: Request supporting data such as migration test results or formulation details

    A letter of compliance is a starting point; manufacturers should obtain supporting data to verify the claim and fulfill their own due-diligence obligations.

  5. Under EU Regulation 10/2011 on plastic food contact materials, what is the overall migration limit (OML) for substances migrating into food?

    Answer: 60 mg/kg food

    EU Regulation 10/2011 sets the OML at 10 mg/dm² of food contact area or 60 mg/kg of food.

  6. Which symbol on a package indicates the material is safe for food contact according to European standards?

    Answer: Fork-and-glass symbol

    The fork-and-glass symbol indicates a material or article is intended for food contact and meets applicable safety requirements.

  7. What does the concept of 'functional barrier' allow in multi-layer food packaging?

    Answer: An inner layer that prevents non-approved substances in outer layers from migrating into food

    A functional barrier is a layer within the packaging structure that prevents non-compliant substances from reaching the food at detectable or harmful levels.