CPT Regulatory Compliance & Food Safety 2 — Questions and Answers
Question 1: Under FDA 21 CFR Part 177, which category of materials is specifically regulated for use in food contact applications?
- Indirect food additives including polymers (Correct answer)
- Direct food colorants and preservatives
- Pesticide residue tolerances on raw produce
- GRAS flavor substances in beverages
Correct answer: Indirect food additives including polymers
21 CFR Part 177 covers indirect food additives such as polymers used in food-contact packaging materials.
Question 2: What is the primary purpose of a migration study in food packaging compliance?
- To measure how much packaging material transfers into the food (Correct answer)
- To test the tensile strength of packaging films
- To validate shelf-life under temperature cycling
- To assess the recyclability of packaging components
Correct 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.
Question 3: Which FDA regulation governs Current Good Manufacturing Practice (cGMP) for manufacturing, packing, or holding human food?
- 21 CFR Part 117 (Correct answer)
- 21 CFR Part 177
- 21 CFR Part 101
- 21 CFR Part 70
Correct 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.
Question 4: A packaging supplier provides a 'letter of compliance' stating their material meets FDA regulations. What additional action should a food manufacturer take?
- Request supporting data such as migration test results or formulation details (Correct answer)
- Accept the letter as sufficient documentation with no further review
- Submit the letter directly to FDA for pre-approval
- Replace the material with one listed on the GRAS database
Correct 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.
Question 5: Under EU Regulation 10/2011 on plastic food contact materials, what is the overall migration limit (OML) for substances migrating into food?
- 10 mg/dm²
- 60 mg/kg food (Correct answer)
- 1 mg/kg food
- 25 mg/dm²
Correct 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.
Question 6: Which symbol on a package indicates the material is safe for food contact according to European standards?
- Fork-and-glass symbol (Correct answer)
- Möbius loop triangle
- CE mark
- Green dot (Grüner Punkt)
Correct 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.
Question 7: What does the concept of 'functional barrier' allow in multi-layer food packaging?
- An inner layer that prevents non-approved substances in outer layers from migrating into food (Correct answer)
- A structural layer that provides burst resistance in retort processing
- A moisture barrier that extends refrigerated shelf life
- An oxygen barrier that prevents lipid oxidation
Correct 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.
CPT Regulatory Compliance & Food Safety 2
Under FDA 21 CFR Part 177, which category of materials is specifically regulated for use in food contact applications?