CPP Regulatory Compliance & Legal Framework 3 — Questions and Answers
Question 1: The EU Packaging and Packaging Waste Directive (94/62/EC) sets essential requirements that include:
- Mandatory use of plant-based inks only
- Limits on heavy metals and minimization of packaging weight/volume (Correct answer)
- A ban on all single-use plastics in the EU
- Requirement for all packaging to carry an eco-label
Correct answer: Limits on heavy metals and minimization of packaging weight/volume
The directive's essential requirements address minimizing packaging weight and volume, limiting hazardous substances including heavy metals (sum ≤100 ppm), and ensuring reuse/recovery.
Question 2: Under REACH regulation in the EU, packaging manufacturers that import or produce chemical substances above 1 tonne/year must:
- Obtain FDA pre-market approval
- Register substances with ECHA (Correct answer)
- File an EPA toxic release inventory report
- Obtain CPSC certification
Correct answer: Register substances with ECHA
REACH requires registration of chemical substances above 1 tonne/year with the European Chemicals Agency (ECHA) before they can be manufactured or imported into the EU.
Question 3: A packaging manufacturer discovers their supplier's ink contains a substance on the EU REACH SVHC Candidate List at >0.1% w/w. The manufacturer's obligation is to:
- Immediately halt production until the substance is removed
- Notify customers and provide safe use information upon request (Correct answer)
- Register the substance with EPA within 30 days
- File a recall notice with CPSC
Correct answer: Notify customers and provide safe use information upon request
Suppliers of articles containing SVHCs above 0.1% w/w must notify recipients and provide information for safe use; consumer notification is required upon request.
Question 4: Which standard establishes testing protocols for child-resistant packaging under the Poison Prevention Packaging Act?
- ASTM D3475 (Correct answer)
- ISO 15223
- ISTA 1A
- MIL-STD-2073
Correct answer: ASTM D3475
ASTM D3475 is the standard consumer safety specification for child-resistant packaging, defining test panels and pass/fail criteria aligned with PPPA requirements.
Question 5: The Lacey Act in the United States affects packaging manufacturers primarily because it:
- Restricts use of endangered animal-based packaging materials
- Prohibits trade in plants and plant products harvested illegally, including wood-based packaging (Correct answer)
- Mandates forest certification for all paper packaging
- Requires labeling of recycled fiber content in paperboard
Correct answer: Prohibits trade in plants and plant products harvested illegally, including wood-based packaging
The Lacey Act prohibits importing, exporting, or selling plants and plant products — including wood pallets and paper packaging — harvested in violation of applicable laws.
Question 6: Extended Producer Responsibility (EPR) laws for packaging, such as those enacted in Oregon and Colorado, require brand owners to:
- Design packaging using only domestically sourced materials
- Fund and manage end-of-life collection and recycling of their packaging (Correct answer)
- Obtain third-party life-cycle assessment certification annually
- Use a minimum of 50% post-consumer recycled content
Correct answer: Fund and manage end-of-life collection and recycling of their packaging
EPR laws shift financial and operational responsibility for packaging end-of-life management from municipalities to the producers who place packaging on the market.
Question 7: FDA's threshold of regulation (TOR) policy allows certain food-contact substances to be used without a food additive petition when dietary concentration is below:
- 0.5 ppb with no carcinogenic potential (Correct answer)
- 0.5 ppm for any substance
- 1 ppm for indirect additives only
- 0.1 ppb for carcinogens
Correct answer: 0.5 ppb with no carcinogenic potential
FDA's TOR policy exempts substances from formal regulation when dietary exposure is ≤0.5 ppb and the substance has no carcinogenic potential, based on negligible risk.
CPP Regulatory Compliance & Legal Framework 3
The EU Packaging and Packaging Waste Directive (94/62/EC) sets essential requirements that include: