Regulatory Compliance & Legal Framework Flashcards
7 cards from real CPP 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 & Legal Framework flashcards as text
The EU Packaging and Packaging Waste Directive (94/62/EC) sets essential requirements that include:
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.
Under REACH regulation in the EU, packaging manufacturers that import or produce chemical substances above 1 tonne/year must:
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.
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:
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.
Which standard establishes testing protocols for child-resistant packaging under the Poison Prevention Packaging Act?
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.
The Lacey Act in the United States affects packaging manufacturers primarily because it:
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.
Extended Producer Responsibility (EPR) laws for packaging, such as those enacted in Oregon and Colorado, require brand owners to:
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.
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:
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.