CPT Regulatory Compliance & Food Safety 2

Question 1

Under FDA 21 CFR Part 177, which category of materials is specifically regulated for use in food contact applications?

Accepted Answer

Indirect food additives including polymers

Answer

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?

Accepted Answer

To measure how much packaging material transfers into the food

Answer

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?

Accepted Answer

21 CFR Part 117

Answer

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?

Accepted Answer

Request supporting data such as migration test results or formulation details

Answer

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?

Accepted Answer

60 mg/kg food

Answer

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

(CPT) Certified Packaging Technologist Practice Test

(CPT) Certified Packaging Technologist Practice Test

CPT Regulatory Compliance & Food Safety 2